ORAL DOSAGE FORM SOPs

1.0 PURPOSE

To describe the procedure for handling of Non-Conformance (NCR). 

• To identify the root cause of non-conformance and to take corrective and preventive actions.
• To avoid/minimize violation of laid down system / procedure / process / specification. 
• To know the effectiveness of lay down system / procedure / process / specification and to identify any improvement. 

2.0 SCOPE:

This SOP is applicable for handling of non-conformance for any product/procedure/activity.

5.0 PROCEDURE:

5.1 ‘Non-conformance Report (NCR)’ shall be generated in case of the following types of non-conformance observations:

i)          Process deviation (from Batch Manufacturing Record)

ii)         Deviation from written procedure (SOP)

iii)        Any GMP related non-compliance observations.

iv)        Non-compliance with in-process specifications.

v)         System deviation/failure.

vi)        Falsification/misrepresentation of document or data.

vii)       Unauthorized changes.

5.2 Any non-conformance observed shall be recorded in ‘Non-conformance Report’. Refer format No.:    JSA/QA/031/F-01/R0

5.3 QA department shall issue the blank format of NCR to concern       department/personnel after allocating     NCR number and making entry in register. Refer format No.: JSA/QA/031/F-02/R0

5.4 NCR number shall comprise of 14 alphanumeric characters as follows,

            JSA/NCR/XX/YYY

            Where,

            NCR    : Non-conformance report

            /           : Separator

XX       : Last two digits of the current year in which the NCR is raised.

YYY    : Serial number of NCR starting from 001 in respective year.

For example, the first NCR number for year 2023 shall be JSA/ NCR/23/001.

5.5      The non-compliance observation shall be classified into critical, major and minor category.  

5.5.1     Critical observation is those which possess a risk of:

i)          Product failure / recall

ii)         Market complaints

1. Serious adverse health consequence or death.
2. Regulatory action

5.5.2    Major observations are those which possess a risk of:

1. Breakdown of equipment/system
2. Yield discrepancy
3. Companies image at stake
4. Major discrepancy like absence or complete breakdown of required systems are observed.

5.5.3     Minor observations are those which possess a risk of:

                        i)          Isolated failure to comply with specified requirement.

                        ii)         Missing out of a product Label in a pack could be considered as a minor. 

5.5.4 The concerned activity shall be stopped immediately after raising of critical/major non-conformance 

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1. PURPOSE

To provide procedure for line clearance.

2.0 SCOPE:

This SOP is applicable to activities during Dispensing, Manufacturing, primary and secondary packing area.

5.0 PROCEDURE:FOR DISPENSING, MANUFACTURING AND PACKING AREA:

5.1       Frequency: After completion of each batch of the product and for product to product.

5.2       Check and ensure entire batch / Product dispensed and manufactured in granulation, compression and coating is transferred to IPC and HDPE containers with poly ethylene covers.

5.3       Check and ensure entire batch / Product is dispensed, manufacturing is transferred to IPC and HDPE containers with poly ethylene covers packed and verify the number of ready for manufacturing labels for and packing labels against the number of container/bags. Verify all the rejects and challenge test specimens are destroyed and recorded in BPR for packing.

5.4       Ensure scrap is removed from the Dispensing, Manufacturing and packing area.

5.5       Reconcile the product and packing materials in BMR / BPR.

5.6       Ensure left over quantity of packing materials are returned to warehouse through MRN or carried forward to the next batch if applicable.

5.7       Update cleaning and equipment usage logbooks.

5.8       Update status board of area and status label for equipment.

5.9       Ensure all the polymer and metal stereos are removed from the machine. Ensure destruction of Polymer stereos and removal of metal stereos for packing.

5.10     Ensure all the samples required for the particular batch has been already collected and recorded in the BMR / BPR.

5.11     Ensure pack stock verification has been completed satisfactorily and ensure any failure during pack stock has been addressed. Ensure primary and secondary packing area is free from any left over’s residues of product and packing materials.

5.12     Identify each printed and overprinted packing materials, attach a specimen of each item duly with “checked by” signed / dated by packing and “verified by” signed / dated by QA.

5.13     Ensure specimen of roll label/ printed foil joints (if any) identified during batch packing duly verified and attached in BPR.

5.14     Verify all the documents relevant to the batch for its correctness and completeness. Shift packaged goods to Quarantine area corresponding to the packing line. Update all checks in BPR checklist and sign/date.

5.2 LINE CLEARANCE FOR RAW MATERIALS DISPENSING: Responsibility: Warehouse

5.2.1 Ensure area ready for line clearance. Initiate Line clearance as per product change over for each batch / each product / after weekends or holiday / after major breakdown.

5.2.2 Ensure previous activity is completed and area logbooks, BMR/s are updated.

5.2.3 Ensure raw materials containers/packs, used dispensing tools and waste is removed from the dispensing booth.

5.2.4 Ensure no damages to floor, walls & ceiling, if any non-compliance inform engineering for rectification and Ensure cleanliness of floor, wall, return air grills, LAF unit, weighing balances, table, printer, light fixtures and vacuum cleaner.

5.2.5 Ensure area temperature and differential pressure is within limit, monochromatic light for light sensitive product is in place and Update respective dispensing booth environmental conditions, monometer readings and performance check of weighing balance.

5.2.6 Update status board of respective dispensing booth.

5.2.7 Check cleanliness of area and accessories, cleanliness of Isolator for specific products and Update respective logbook with cleaning details.

5.2.8 Check all the check points for compliance and tick ‘√’ the check points in BMR, line clearance column and Update BMR with previous product and batch No., Sign with date and time. In case of Non-serial cleaning, inform QA for line clearance and affix cleaned label to BMR.

5.2.9 Carry out the line clearance checks and sign in appropriate columns with date & time. For non-compliance/failure refer SOP No. JSA/SOP/QA/031.

5.3 LINE CLEARANCE FOR MANUFACTURING ACTIVITIES:

5.3.1 Initiate Line clearance before start-up of activity for each batch / Product, beyond cleaning hold time/ after major breakdown.

5.3.2 Ensure previous activity is completed and area, equipment logbooks are updated and Ensure previous product containers/bags, BMR and waste is removed from the process area. 

5.3.3 Ensure no damages to floor, walls and equipment are present, any non-compliance inform engineering for rectification.

5.3.4 Ensure area temperature, % of relative humidity and differential pressure as applicable, is within limit of area specification, monochromatic light for light sensitive product is available.

5.3.5 Update status board of respective area and affix status labels for equipment as applicable and Check cleanliness of area, equipment’s and accessories.

5.3.6 Update respective process area and equipment logbooks for cleaning, environmental conditions and performance check of weighing balance, as applicable. 

5.3.7 Enter the area and equipment ID in applicable columns and tick ‘√’ for equipment ID and reference SOP/WI in the BMR line clearance column. Record previous product and Batch No. in appropriate columns.

5.3.8 Ensure logbooks updated, proper status labelling and environmental conditions are complying with product requirement and Sign with date in done by column.

5.3.9 Check all points for compliance, use illumination device, mirror as appropriate and tick ‘√’ the check point in BMR line clearance column for area and equipment as applicable and In case of Serial cleaning, sign with date and time in ‘Checked by’ column for commencement of process.

5.3.10 In case of Non-serial cleaning, ensure floor, walls, inlet/exhaust air grills, weighing balance & light fixtures are clean. Ensure correct / validated equipment is taken for process as per BMR. Perform line clearance checks, before and after assembling of machine, as per BMR requirement.

5.3.11 In case of first line clearance for new equipment ensure all qualification, activities are completed and equipment is ready to use.

5.3.12 Check cleanliness of accessories, vacuum cleaner, product holding containers, inner & outer surface of equipment’s, wheels, lids and other specific check points of equipment as per BMR.

5.3.13 During Line clearance, additional to the BMR check points, carryout comprehensive and explicit checks on Area, Equipment & accessories, ensure for the following;

1. No shredding from product contact parts of machine / equipment / accessories.
2. No missing screw holes or loose screw or rusted screw is available.
3. No Teflon flagging is available.
4. No abnormal sound or odour.
5. No loose, damaged part of equipment / accessories.
6. No damages in compressed air line/ vacuum line or other utility lines.
7. No damages at electrical connections switches, sockets / plug points.
8. No manually written labels on machine, apart from calibration/PM status and status label.
9. Personnel safety fixtures of machines are in working condition (e.g. damaged handle of acrylic guard, blockage of sensor etc.).
10. Absence of adhesive tape or marks.
11. All utility points and tool boxes are cleaned, closed and in labelled condition.
12. All product transfer trolleys & its wheels are free from rust, dust, any damages or obvious stains.
13. Presence of proper indicative marks / bands for Direction of rotation, utility lines, flow direction etc.
14. Panels, platform, ladders and stair case are free from dust, rust, extraneous stains and damages.
15. Top and bottom surfaces are free from dust, rust, crack and damage.
16. View glass on equipment is intact and free from cracks or damages.
17. Integrity of filters and gaskets.
18. Proper arrangement of change parts / accessories to avoid damage.
19. Cleanliness of scoops / spoons / saddles / containers and other accessories.
20. Other unused fixed equipment’s / machines in the same area are cleaned, labelled& stretch wrapped.

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1.0 PURPOSE

The purpose of this document is to provide a procedure for destruction of materials which are rendered unsuitable for effective usage.

2.0 SCOPE:

This SOP covers all the materials which are rendered unsuitable for manufacturing

5.0 PROCEDURE:

5.1 RAW MATERIALS:

5.1.1 The materials covered under are raw materials used for manufacturing of all batch(s), it also includes materials used indirectly for manufacturing the batch(s) excluding process water.

5.1.2 These raw materials which are rejected on account of processing by way of spillage, traces in Containers, machineries, residual losses and process rejects shall be collected, added to Water and drained down. Liquids shall also be diluted in water and drained

5.2 BULK PRODUCTS:

5.2.1 This includes dried granules, Lubricated granules and tablets.

5.2.2 These dried granules, Lubricated granules and tablets are rendered as rejects in normal processing due to spillage, spoilage due to oil / grease / fuels, Spoilage on machine due to heat or rubbing and other processes rejects that are non recoverable in nature.

5.2.3 These items shall be dispersed in water and drained out.

5.3 GLASS BOTTLES AND PLASTIC BOTTLES:

5.3.1 These items are rendered rejects due to spoilage due to machine working, physical damage during handling and change in color or shape.

5.3.2 These items should be destroyed and disposed as scrap.

5.4  PRINTED PACKAGING MATERIALS:

5.4.1 These are secondary packaging materials used in enclosing the primary container and this also includes primary packaging materials such as printed aluminum foils etc., used to pack the product which gives an identity to the product in market. Control of these items has quality, commercial and legal implications.

5.4.2 These items are rendered rejects due to overprinting, spoilage due to machine working, physical damage during handling and poor or improper printing at supplier’s end.

5.4.3 Excess printed items left out after packaging due to variation in yields shall also be treated as surplus rejects.

5.4.4For the purpose of operational convenience, the polymer stereos are also classified as printed PM and is destroyed after use in presence of QA before line clearance is given for next batch.

5.4.5 These rejects shall be torn physically in the presence of packaging in-charge.

5.4.6 The quantity torn shall be accounted in the respective batch records and also shall be shown in the packaging material reconciliation sheet of the respective BPR. These torn items must be preferably incinerated beyond recovery.

5.4.7 Rejections generated during online packaging includes improper printing on aluminum foil, scratches, dull printing etc, in case of material rejections during usage such online rejections shall be returned to stores through MRN along with rejected status label and follow the procedure as per the respective SOP.

5.5 UNPRINTED PACKAGING MATERIALS:

5.5.1 This constitutes the outer packaging which renders it easy for handling and transportation. These are normally tough enough to withstand process handling.

5.5.2 These are rendered rejects due to drenching, rupture, poor pasting and staining due to oil /ink. These rejects must be torn off and duly accounted.

 5.6 DESTRUCTION OF REJECTS DUE TO UNUSUAL OCCURRENCES:

5.6.1 When any of the above-mentioned items are rendered rejects due to an unusual occurrence the involved quantity will normally be much more than the allowable tolerance levels.

5.6.2 In such condition’s the problem shall be intimated by the concerned department in writing to the department head and there upon it will be investigated in coordination with QA to assess the extent of rejection.

5.6.3 Thereafter the item in the mentioned quantities shall be declared “TO BE DESTROYED” in consultation with the clients and a destruction form shall be filled. (Refer Annexure - 1)

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1.0 PURPOSE

To provide a detail procedure for operation qualification, performance evaluation during the performance qualification (PQ) and periodic re-qualification (RQ) of heating ventilation and air conditioning (HVAC) systems.

2.0 SCOPE:

This SOP is applicable for the operation, performance qualification and periodic Re-qualification of all heating ventilation and air conditioning (HVAC) systems with the clean rooms associated (together with all associated structures, air treatment systems, services and utilities), installed at all manufacturing facilities .

Air ventilation units or air handling units associated to any uncontrolled / unclassified area and without any HEPA filter installed in it, is not in the scope of this SOP.

5.0 PROCEDURE:

5.1 Air Velocity

Calculate the total room CFM or CMH if the number of filters is more than one in a room by adding the total CFM or CMH of individual filter.

Calculate the total air changes per hour as per the following formula.

Total Air changes per hour for a particular room =       Total Room CFM x 60_

                                                                                      Volume of the Room (ft³)

Or

Total Air changes per hour for a particular room =       Total Room CMH_____

                                                                                     Volume of the Room (M³)

Acceptance Criteria:

Calculated air changes per hour / air exchange rate should not be less than the required or designed air changes per hour for respective room.

Frequency: Once in a Year

5.2 AIR PRESSURE DIFFERENCE (DIFFERENTIAL PRESSURE) TEST:

The purpose of this test is to verify the capability of HVAC system is maintaining the specified pressure difference between the installation and its surroundings areas and between the separate rooms with in the installation.

This test can be repeated on a regular basis as part of routine in process monitoring program and shall not be a part of RQ protocol.

Instrument: Electronic pressure recorder or Magnehelic gauges.

Before starting air pressure difference test, the air flow velocity and air changes requirement shall be within the specifications.

With all doors closed, the pressure difference between the clean rooms and all related surrounding areas shall be measured and recorded.

If the area is subdivided into more than one clean room, the pressure differences between the innermost room and the next adjacent room shall be measured.

At the time of initial qualification pressure difference shall be monitored continually for minimum three days with a minimum reading frequency of every four hours for particular area.

Note: Wherever Building management system (BMS) is installed & qualified – Manual monitoring of Differential Pressure is not necessary. BMS monitored data of differential pressure shall be considered.

Acceptance Criteria:

The differential pressure measured for each clean room shall be 10 to 20 Pascal with respect to its adjacent area of lower cleanliness (with doors closed).

If the facility is designed with an unclassified room adjacent to Classified room, the differential pressure measured shall not be less than 12.5 Pascal at all the time.

The differential pressure measured shall 5 to 15 Pascal with respect to its adjacent area of same cleanliness class.

5.3 FILTER SYSTEM LEAKAGE TEST:

Procedures for Installed Filter System Leakage Scan Test.

The purpose of this test is to confirm that the filter system is properly installed and that leaks have not developed during installation and / or use.

Equipment: “Polydisperse aerosol generator” and “Aerosol photometer” The equipment used for the leak testing is - light scattering type with a threshold sensitivity of at least 10^-3 mcg/Lt. Capable of measuring concentration in the range of 10 - 100 mcg/Lt. with an air sample flow rate of at least 1 cubic ft per minute.

This test shall be conducted for all the HEPA filters having 99.97% and above efficiency only.

Filter leak test should be conducted after operational airflow velocity/air volume is checked and certified.

The concentration of aerosol challenged upstream of the filter should be between 20 mg/m³ to 80 mg/m³. (As the concentrations lower than 20 mg/m³ can reduce the sensitivity for leak detection & the concentrations greater than 80 mg/m³ can give rise to excessive filter fouling over an extended test period).

The test is performed by introducing the PAO aerosol challenge upstream of the filter and scanning the downstream side of HEPA filter media, frame, gasket and grid or mounting frame system with the photometer probe to find the leakage.

To have a homogenous mixing of an aerosol added, align the aerosol generator at the return air duct or supply plenum duct of that HVAC system/ clean room.

Remove the filter grill of the Terminal HEPA filter, if the grills are available.

Set the upstream as 100% by measuring aerosol concentrations at the testing port provided on the terminal filter box end (where the test port is not available upstream can be measured and set as 100% at the return duct or from the Magnehelic gauge tubing of the same HVAC system).

Find the penetration of the aerosol in percentage at the downstream by scanning the filter face by moving the sensor probe with slightly overlapping strokes. The probe should be held in a distance of approximately 3 cm from the downstream filter face or the frame structure.

The traverse scan rate should not be more than 10 ft/min (5cm/second).

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1.0 PURPOSE

To provide procedure for cleaning, operation & calibration of balance(s) used in warehouse, manufacturing and packaging area

2.0 SCOPE: 

This work instruction is applicable for cleaning, operation & calibration of balance(s) used in warehouse, manufacturing and packaging area

5.0 PROCEDURE:

5.1       Procedure for cleaning of balance:

5.1.1     Switch ‘OFF’ the balance by operating main switch. 

5.1.2     Clean the weighing balance and weights with lint free cloth using 70% IPA solution at the start of shift and at the end of the shift. 

5.1.3     After every usage clean the balance with lint free clean & dry cloth

5.2       General Conditions and Precautions:

5.2.1     Balance shall be placed at location with sufficiently low level of vibrations and air current.

5.2.2     Balance and surrounding of the balance shall be kept clean after each operation. 

5.2.3     Before using for measurement, ensure that balance is calibrated.

5.2.4     Keep charged self indicating silica gel in the weighing chamber of Analytical balance.

5.2.5     Use certified calibrated weight(s) for calibration of balance(s).

5.2.6     Allow samples/containers to reach ambient room temperature before weighing. Hot samples will generate an upward convection of warm air that will cause an inaccurate reading.

5.2.7     Samples that are extremely hygroscopic must be rapidly weighed in a closed container.

5.2.8     Volatile liquids must be weighed in a closed container.

5.2.9     Balance shall not be moved from one place to other place once calibrated. If it is required to move for any reason then first it should be levelled and allowed to adjust to the temperature of its new environment and be recalibrated.

5.2.10   Usage (working) capacity of the balance shall be displayed for accurate weighing and to prevent damage to balance. The usage capacity shall be about 80% of higher weighing capacity of balance and minimum 50 times of the least count of the balance.

5.2.11   Fingerprints may cause an inaccurate value. Make sure hands are clean and dry and do not contribute to the weighing.

5.2.12   Allow the balance and weight(s) to stabilize to the ambient working temperature before operation.

5.2.13   Do not allow the material to remain on the balance for an extended period of time because changes, caused by interaction with atmospheric water or carbon dioxide, may take place.

5.2.14   If more than one weight required during calibration then place the weights one upon other as for as possible.

5.3       Procedure for calibration of balances:

5.3.1     Daily verification of balances against standard weights:

5.3.1.1  Check the electric connection of instrument.

5.3.1.2  For balances having inbuilt spirit level check that the spirit level is at the center of spirit scale before calibration, if not bring the spirit level to the center of the scale by rotating the level screw at the bottom of respective balance.

5.3.1.3  For balances without inbuilt spirit level, place the spirit level meter at the center of the pan/platform of the balance. If spirit level is not at the center of the scale, adjust the spirit level indicator to the center of the scale by rotating the level screw at the bottom of the respective balance.

5.3.1.4  Switch ON the mains of the instrument.

5.3.1.5  Allow at least 30 minutes for initial warm-up.

5.3.1.6  After warm-up carry out the verification of balance with standard weights.

5.3.1.7  Auto zero the balance and place weight on the weighing pan/platform, wait till the reading gets stable. Note down the reading.

5.3.1.8   Get the pre calibrated standard weight box for verification of balance.

5.3.1.9  Place the standard weights specified at the centre of the weighing balance platform in ascending order. Ensure that the standard weights (for analytical balances) are handled with the forceps.

5.3.1.10 Daily verification range to be calculated as below:

Minimum verification range of each balance = Least count x 50

Maximum verification range = 80 % of each balance maximum Capacity.

Middle verification range= 50 % of the maximum Verification range.

For Example: 150 Kg. max. Capacity balance, which least count is 0.01 kg. then

Min. Verification range= 0.01 x 50= 0.5 kg.

Max. Verification range = 150 x 80/100 =120 kg.

Middle verification range= 50 % of max.=60 kg

If calculated value not found in round figure than we will take round up of weight.

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1.0 PURPOSE

To lay down a standard guideline for Equipment / Facility qualification i.e. to initiate, conduct and document Equipment / Facility qualification studies.

2.0 SCOPE:

This standard procedure is applicable to all new, upgraded, relocated process related Equipment / Utility and facility.

5.0 PROCEDURE:

5.1 Preamble & Introduction

5.1.1 All equipment in the facility shall be categorized in to Direct Impacting, Indirect Impacting and No Impacting and accordingly extent of Qualification shall be decided. Whenever new equipment is  introduced in the facility (an equipment type for which categorization is not performed), its categorization shall be carried out.

5.1.2  All personnel involved in preparing Qualification documents must be trained on site qualification procedure for preparing qualification document and personnel involved in the execution of the  protocols shall be trained for the specific activities, prior to their work.  The training must be documented in the protocol.

5.1.3    All qualification activities shall be carried considering life cycle approach, consisting of following three stages of life cycle:

5.1.4    All above stated Qualification activities shall be linked with each other as mentioned in the ‘V Model of Qualification’. Test to be carried out and respective acceptance criteria for installation qualification, operation qualification and performance qualification shall be referred from design qualification / specification, functional specification and user requirement specifications respectively

5.2  Equipment Qualification

5.2.1 Refer to the below flow of the qualification plan, each step of the qualification defined further. Each   site has to prepare equipment qualification master plan defining the responsibility, scope and format     of qualification document and strategy to qualification.

5.2.3 User Requirement Specification (URS)/Functional requirement Specifications (FRS)

5.2.3.1  A requirement specification that describes what the equipment or system is supposed to perform, thus containing at least a set of criteria or conditions that have to be met. The User Requirement Specifications (URS) are fundamental informational components that serve as the basis for design / development of equipment / utility / facility.

5.2.3.2        The URS is made to provide documented requirements of user for Equipment/Utility/Facility,     which includes establishment of critical operating or operational parameters or specifications.        URS shall have brief description of the equipment, GMP aspects like material of construction of parts, accessibility of cleaning of equipment and its parts, capacity, speed, process requirements,          safety, personnel safety, location suitability, details of utilities required (available at site), process constraints (if any), environmental conditions at site, specification of equipment at in feed and out feed, if any.

5.2.3.3        URS may also have nature of products to be handled, critical process parameters to be controlled, regulatory requirements, level of automation (interlocks, PLC, MMI), Power failure and recovery, emergency stop for machine, alarm warnings, data security, sterilization requirement (if any), documentation required (for example P&ID diagrams, specification of capacities.) and training.

5.2.3.4        URS for Direct and indirect impact equipment / utility / facility shall be developed based on previous knowledge, product and process requirements and current industry practices.

5.2.3.5        User department shall prepare the URS of required equipment/facility/services.

5.2.3.6 Each requirement mentioned in the URS shall be numbered to maintain the traceability with qualification tests.

5.2.3.7  The URS shall have following contents but not limited to:

5.2.3.7.1  Purpose

5.2.3.7.2  Scope and Responsibility

5.2.3.7.3   System Description / Technical Specifications / Working Principle.

5.2.3.7.4   User Requirement Specifications

5.2.3.7.5.   Documentation Requirements: - Write the details of documents required along with the machine as:

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1.0 PURPOSE

To lay down a procedure for operation, cleaning & calibration of disintegration test apparatus.

2.0 SCOPE:

This procedure is applicable for operation, cleaning & calibration of disintegration test apparatus in  the Production (IPQC) and Quality control departments.

5.0 PROCEDURE.

5.2.1      For uncoated tablets

5.2.1.1 Introduce one tablet into each tube and add a disc to each tube. Suspend the basket assembly in the beaker containing specified liquid.

5.2.1.2        Operate the Apparatus for the time specified in the respective Batch Manufacturing Record.  Remove the assembly from the liquid.

5.2.1.3        Tablets pass the test if all six have disintegrated. If one or two tablets fail to disintegrate then repeat the test with twelve more tablets, not less than sixteen of the total of eighteen tablets tested disintegrate completely.

5.2.1.4   If any tablet fails to disintegrate because of sticking with the disc then      perform the test without disc.

5.2.2           For film coated tablets

5.2.2.1        Introduce one tablet in to each tube and add a disc to each tube. Suspend the Basket assembly in the          beaker containing specified liquid.

5.2.2.2        Operate the Apparatus for the time specified in the respective Batch Manufacturing Record.

5.2.2.3        Remove the assembly from the liquid. Tablets pass the test if all six have disintegrated.

5.2.2.4        If any tablet fails to disintegrate because of sticking with the disc then perform the test without disc.

5.2.2           For delayed – release (enteric coated) tablets

5.2.2.1        Introduce one tablet in to each tube, suspend the assembly in the beaker containing 0.1 M hydrochloric acid and operate without the discs for 120 minutes.

5.2.2.2        Remove the assembly from the liquid. No tablet shows signs of cracks that would allow the escape of    the contents or disintegration, apart from fragments of coating.

5.2.2.3        Replace the liquid in the beaker with mixed phosphate buffer pH 6.8,add a disc to each tube and       operate the apparatus for a further 60 minutes. Remove the assembly from liquid.

5.2.2.4        If the tablet fails to comply because of adherence to the disc, repeat the test on a further 6 tablets omitting the discs. The tablets pass the test if all six have disintegrated.

5.2.2.5 If one or two tablets fail to disintegrate then repeat the test with twelve more tablets, not less than   sixteen of the total of eighteen tablets tested disintegrate completely.

5.2.4     For Hard gelatin capsules

5.2.4.1 Introduce one Capsule in to each tube and add a disc to each tube. Suspend the basket assembly in the beaker containing specified liquid.

5.2.4.2 Operate the Apparatus for the time specified in the respective Batch Manufacturing Record.   Remove the assembly from the liquid.

5.2.4.3 Capsules pass the test if all six have disintegrated. If one or two capsules fail to disintegrate within   30 min, then repeat the test with twelve more capsules, not less than sixteen of the total of eighteen capsules tested disintegrates completely.

5.2.5           For  dispersible  tablets

5.2.5.1        Introduce one tablet in to each tube and add a disc to each tube. Suspend the basket assembly in the beaker containing specified liquid. Maintain the temperature at 24 ° C to 26 ° C.

5.2.5.2        Operate the Apparatus for the time specified in the respective Batch Manufacturing Record. Remove the assembly from the liquid. Tablets pass the test if all six have been disintegrated.

5.2.5.3  FINENESS OF DISPERSION

Take 100 ml of purified water in a 250 ml glass beaker Maintain the temperature at 24 °C to 25 °C. Add two tablets and stir until completely dispersed.

5.2.5.4 Then pass the suspension through the screen with a nominal mesh aperture of 0.710 mm(22 # sieve.) Tablets pass the test if no particle retained on the sieve.

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1.0 PURPOSE

 To provide a procedure for conducting In-process Quality Assurance checks during various stages of     manufacturing and packaging for all products manufactured

2.0 SCOPE:

Covers all in-process checks for all products manufactured and packaged in the facility.

5.0 PROCEDURE:

5.1 GENERAL CHECKS

5.1.1 Check the status boards, status labels which displayed outside each area of activity and ensuring its          correctness and completeness.

5.1.2 Receive Test Request Form at applicable stages from production and ensure for its correctness.

5.1.3 Perform line clearance for the specific area checks wherever necessary as per “line clearance for manufacturing or packing area as per SOP No. JSA/SOP/QA/032

5.1.4 Check the logbooks and ensure for its correctness and completeness.

5.1.5 Before Dispensing, verify the potency calculation for active materials and put a sign in “verified by” column in the calculation sheet of BMR.

INPROCESS TEST PARAMETER FOR TABLET PRODUCTION DEPARTMENT: 

INPROCESS TEST PARAMETER FOR CAPSULES PRODUCTION DEPARTMENT:

INPROCESS TEST PARAMETER FOR LIQUID PRODUCTION DEPARTMENT:

INPROCESS TEST PARAMETER FOR PACKAGING DEPARTMENT:

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1.0 PURPOSE

To provide a procedure for handling of returned drug products.

2.0 SCOPE:

It is applicable for receipt, handling, storage, packing, resale or destruction of returned drug products produced

5.0 PROCEDURE:

5.0 PROCEDURE

5.1 Returning of drug products may arise out the following:

• Market complaint from customer or contract giver, e.g. product mix-ups, label mix-up, physical and visual deterioration like significant discoloration, sedimentation, crystallization, etc, or any significant quality defect as over potency.
• Request by regulatory agency.
• Report of adverse reaction to a particular batch of a product reported by customer of regulatory agency.
• Recall initiated due to self-identified reasons.

5.1.1 Any such event requires notification to senior management.

5.2 Returning procedure:

5.2.1 Notification and creation of return order

• Marketing personnel shall send notification to QA department.
• After approval of QA, marketing personnel shall generate return order.
• Goods shall be delivered to respective warehouse of Site
• QA shall allot number for notification as follow: JSA/RG/001/2023, where RG; returned goods, 001 stand for sequential serial number for notification in year of goods return.

5.2.2 Handling of returned drug product

5.2.2.1 Follow these SOPs, when needed, as applicable:

5.2.2.2 dentify returned product with “Returned Product” label (Annexure 3), for better identification and to prevent mix-ups.

5.2.2.3 Transfer the product as per their storage requirements to respective area provided for returned goods in finish goods store.

5.2.2.4 Update the returned drug product log (Annexure 1)

5.2.3 Warehouse Head shall receive the applicable drug product, and check it against documents.

• SOP titled “Deviation Management”
• SOP titled “Product Recall”
• SOP titled “Handling of Market Complaint”

5.2.4 Any return as stated in 5.1 shall be investigated by QA Head along with concerned department.

5.2.5 A detailed report on the investigation, probable cause leading to the event and further corrective and preventive actions, if any, shall be documented in forms attached to respective SOP.

• Procedure for correction

5.2.6 QA Head shall review the data on returned goods and critically assess the quality, nature of product, any special storage condition, history, time elapsed since it was issued, etc. for future disposition actions.

5.2.7 The “authorization for destruction” shall be sent to warehouse Head by QA Head/Designee after a decision of rejection is taken.

5.2.8 Where applicable, sampling shall be initiated as per respective SOP/WI

5.2.9 The observation during sampling shall be recorded in “observation sheet on returned drug product” (Annexure 2) and sent to QC for analysis.

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1.0 PURPOSE

To provide a procedure for release of Finished Goods.

2.0 SCOPE:

The SOP is Applicable for all products to be release for sale and distribution after packing

5.0 PROCEDURE:

5.1 Head/designee Production shall review the batch document after completion of batch packing and  submit it to the QA for review along with the review checklist.

5.2   QA/IPQA shall review the batch Documents as per the checklist and ensure the completeness and correctness of filled record. Verified the checklist and put sign and date in the checklist attached with Batch document record.

5.3  Review the completeness of batch packing records against the procedure mentioned for operating parameters, in-process checks results and entries filled, attached labels, printed packaging material proofs, batch reconciliation for packing material and finished products.

5.4 Head-QA/Designee shall review the certificate of analysis received after analysis from QC, and check the results against specification limit. Put a sign and date along with mentioning reviewed by.

5.5 Enclose the reviewed certificate of analysis along with batch packing record and issue a batch release certification, same batch release certification sign by approved technical chemist/pharmacist.

5.6 Send a copy of batch release certification to finished good warehouse along with copy of certificate of analysis received. A copy of the batch release certification shall be enclosed with batch packing record.

5.7 Archive the batch packing record in the record room as per SOP on the document and data control

5.8 In case any deviation is observed in the batch packing record or analytical record raise the deviation and investigation.

5.9 Authorized person shall release the batch  

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