ORAL DOSAGE FORM SOPs

1.0 PURPOSE

To provide procedure for issuance and control of forms and logbook for documentation purpose.

2.0 SCOPE:

Cover all forms and logbook used in the QA, QC, Production, Warehouse, Engineering, EHS and   HR&A  

5.0 PROCEDURE:

5.1  The following are the details of forms and logbook used in the location.

5.2       A written record of cleaning, maintenance and use shall be included in the individual equipment Logs that show the date, time, product, lot/Batch No. of each batch processed.

5.3       All entries in logbook should make in chronological order.

5.4       Issuance and control of forms:

5.4.1     Whenever a condensed version of format is approved as part of SOP, a master copy shall be       approved by the Head QA on the actual effective date of the SOP after applicable training   and a photocopy used for routine documentation.

5.4.2    Forms which are pre-printed / numbered can be used directly for routine documentation which shall be controlled by concerned department head.

5.4.3    It is the responsibility of concerned department head to ensure that current forms are in use.

5.4.4    In case of revision of forms, concerned department head or their designee shall ensure that current Forms are not available / used in the department from the effective date of the new format.

5.5       Issuance and control of log book:

5.5.1    All log books shall be issued by Quality Assurance.

5.5.2    The numbering to the Logbook shall be as JSA/Dept. Code/YYY/001. e.g. the first logbook issue to engineering department in the year of 2023 shall be numbered as JSA/ENG/2023/001

5.5.3    Make an issuance logbook for each department for easy tracking of issuance and retrieval.

5.5.4    It is the responsibility of the concerned department heads to procure required number of log book.QA shall arrange to issue the log book as per requirement.

5.5.5    Respective department head shall ensure that any new log book introduced shall be part of the documentation as provided in the SOP.

5.5.6    Issue all log books after filling details in “Issuance and control of log books” (Annexure -I). At the time of issuance, QA shall verify the format details printed in log book with respective SOP.

5.5.7    Use pre-numbered and bound log book bearing the company name.

5.5.8    All log books shall be issued at the beginning of January or as per requirement.

5.5.9    At the time of issuance/ re-issuance, ensure that used log book are closed and signed off by QA.

5.5.10 Prior to archival under the safe custody of QA head/ concerned department head.

5.6       Review of log books:

5.6.1    Entries in the log book shall be done by the doer of the activity as applicable. All entries shall be verified by the supervisor concurrently or reviewed by department head or his /her designee at a periodicity of minimum once in 30 days.

5.6.2    QA review of logbooks shall be as follows:

5.6.2.1 Log books of critical process/equipment /Area, as identified by respective department head and QA: once every month (30 days) or earlier.

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1.0 PURPOSE

To provide procedure for handling of interruptions in manufacturing.

2.0 SCOPE:

It is applicable for handling of interruptions arising due to machine setting, stoppages, power failure and break down of equipments in manufacturing and packing area.

5.0 PROCEDURE:

5.1       The instances for interruptions in manufacturing areas are, but not limited to:.

5.1.1     Stoppage for breakfast, lunch, dinner, holidays and prays.

5.1.2     Stoppage for shift end / holiday.

5.1.3     Set parameters excursion reported.

5.1.4     Resetting of machine.

5.1.5     Machine break down.

5.1.6     Power failure.

5.1.7     Environmental conditions beyond limits.

5.2       In case of stoppage for breaks at breakfast/ lunch/dinner/ shift end, stop the activity /machine as  applicable, stoppage not permissible for activities like Mixing, Drying, Melting, Blending, Encapsulation, coating etc.

5.2.1     In case of weekends / holydays, complete the step / unload the product from the equipments as  applicable. Example: in compression, encapsulation, unload the product, in case of (Blending, mixing, Drying, Coating) complete the step / stage and unload the product.

5.2.2     Cover the opened process equipments with lid / poly bags with status label.

5.2.3     Lock the process area to restrict the personnel movement in the applicable areas, if required.

5.3       In case of interruption due to restart / resetting of machine / parameter, follow the specific instructions for respective activity mentioned below:

5.3.1     In case of Granulation stage ensure opened IPC are closed, inform supervisors and ensure correct set parameters.

5.3.2     In case of blending stage ensure opened IPC are closed, inform supervisors and ensure correct set parameters.

5.3.3     In case of compression stage put poly bag to discharge chute, complete the resetting, reject    initial 2 rounds of tablets and weight and record the rejected quantity.

5.3.4     In case of coating stage stop spraying, continue the rotation of pan, inform the supervisors, start stirring of coating solution and ensure correct set parameters.

5.3.5     In case of encapsulation stage put poly bag to discharge chute, complete the resetting and weight and record the rejected quantity.

5.3.6     Reset the machine, as applicable. Ensure the compliance with environmental conditions in resumption.

5.3.7     Perform the in-process check as per BMR immediately after resumption, if found  satisfactory continue the process, if not reset the parameters and continue.

5.3.8     Discard the tablets / capsules generated during setting, update the logbook and BMR.

5.4       In case of interruptions due to power failure / break down of machine, switch off the mains   and follow the specific instructions for respective activity as mentioned below:

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1.0 PURPOSE

To provide procedure for Monitoring of Environmental conditions.

2.0 SCOPE:

This SOP is applicable to Manufacturing facility

5.0 PROCEDURE:

5.1  Monitor and record the temperature and relative humidity (as applicable) twice daily i.e. while start of the shift/Activity and at the end of the shift. In case of extending working hours recording shall be done after every 4 hours apart from schedule. In-case of no activity in the areas recording shall be done once in a day. Weekends and holidays are excluded from the scope of this SOP.

5.2 Fill the observed reading in respective column in logbook. Check if an observed reading is within limit. If not inform to Head-QA / Designee and take corrective actions and preventive actions as applicable.

5.3 Done by column shall be filled by respective department and checked by shall be done by incharge of respective section for the respective areas.

5.4 Limit for temperature and Relative humidity is mentioned below.

5.5  Areas where relative humidity is not applicable mention as NA (′Not Applicable′). Temperature humidity shall not be recorded for comfort areas.

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1.0 PURPOSE

To provide procedure for sampling of products at intermediate and final stage of manufacturing process.

2.0 SCOPE:

This work instruction is applicable to sampling of products at intermediate and final stage of  manufacturing process.

5.0 PROCEDURE:

5.1       The process of performing sampling of products in manufacturing is stated below:.

5.2       Production.

5.2.1     Check for the completion of stage process. Intimate QA for Collection of validation samples as per the respective product protocol.

5.3       QA.

5.3.1       After blend reconciliation by production, verify all the containers / IPC against the BMR entries.

5.4       Production.

5.4.1   Prepare TRF for sampling at different stages of manufacturing, based on the product protocol or BMR  instructions and submit to QA for sampling. Annexure-1

5.4.2    Confirm the sample quantity and write the confirmed status in remarks of TRF.

5.5       QA

5.5.1   Ensure cleanliness and correctness of sampling accessories.

5.5.2   Label the polybag / glass bottle / vials with batch details. Ensure black color poly bag or amber color glass bottle/vials are used for light sensitive products.

5.5.3   Check the product container label for product details and collect the required samples as per below table or as specified in BMR/Protocol/STP.

5.5.4   For uncoated tablets and hard Gelatin capsules collect samples during initial, middle and end of  compression or filling activity.

5.5.5    Collect the sample for chemical and for microbiology analysis as per protocol at each stage of process and store sample poly bag/PET container in sample box in same process cubicle.

5.5.6    For Coated tablets collect samples from each lot per protocol.

5.5.7    For Liquids and ointment collect samples as specified in the protocol.

5.5.8   After completion of batch, transfer the samples to pre labeled poly bag/PET Container.

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1.0 PURPOSE

To provide procedure for describing the responsibilities of Quality Unit.

2.0 SCOPE:

This procedure is applicable to Quality Control and Quality Assurance units

5.0 PROCEDURE:

5.1 Responsibilities of Quality Assurance Unit includes the following, but not limited to:

5.1.1 Ensure that the Quality Management System is designed, implemented, monitored, reviewed and improved on a continual basis through clearly defined procedures and practices.

5.1.2 Preparation, review, authorization and ensuring compliance of site specific/harmonized procedures, as applicable.

5.1.3 Preparation, review and approve/ authorize master directive document (e.g. VMP, SMF, validation  protocols, reports, Quality manual etc.) and ensure that manufacturing processes are carried out using correct starting and packing materials.

5.1.4 Ensure that validation/ calibration activities pertaining to equipment/utilities/products/processes/    systems are maintained current and compliant.

5.1.5 Initiate/conduct/participate/ respond appropriately in investigation arising out of deviations/ failures/compliant/recalls/OOS/OOT/OOC/returned goods with all applicable cross functions to arrive at resolution and appropriate CAPA. Where applicable ensure customer/regulatory communications    are promptly escalated and addressed.

5.1.6 Sample semi-finished, finished products, stability samples, retention samples, validation samples, etc.   as per predefined procedures/protocols.

5.1.7 Conduct various in-process checks, line clearance, reconciliation verification during various stages of  batch manufacturing for ensuring overall production and process control correctness. Deviations, if  any, are investigated and resolved.

5.1.8 Review of batch records at all relevant stages and authorize release of batch for distribution/sale as per    procedures after ensuring that:

1. Batch has met pre-determined specifications, marketing authorization requirement, applicable customer and regulatory requirement.
2. Deviations/errors (observed if any) have been documented and fully investigated.

5.1.9 Ensure that external service providers are selected, qualified and controlled as per written down procedures/agreements.

5.1.10 Compile/evaluate annual product quality review data for initiating applicable actions, as required. Perform/review periodic trend reports of applicable data e.g. ; EMP, water, OOS, deviations etc. as defined in procedures and identify opportunities for improvement actions.

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PURPOSE

To lay down the procedure for Authorization ask and destruction of rejected, online   rejected, damaged and expired goods.

SCOPE:

Procedure is applicable for authorization and destruction of rejected, on line rejected, damaged and expired goods

5.0 PROCEDURE

5.1 Aauthorization for destruction of rejected, damaged and expired goods.

5.1.1 Any material /product to be destroyed shall be identified by concern department on the following basis but not limited.

5.1.2 RAW MATERIAL: Rejected material by Quality control, Expired material, Spillage material and mix up of two materials.

5.1.3 PACKING MATERIAL: Rejected material, Printed material not in use and mixed labels.

5.1.4 BULK AND FINISHED PRODUCT: Rejected, Spillage product, Expired product, Market return (expired and unsafe product) and Mixed products that can’t be segregated.

5.1.5 Concern department shall raise request for destruction Authorizations of Material Destruction to Quality assurance department.

5.1.6 QA head or his designate shall inspect the material on site and put signature form.

5.1.7 Finally Quality Head and Plant Head shall authorize the destruction.

5.1.8 If request form approved for destruction. A copy of such form shall submit to account department and Q.A head shall inform to concern department head to arrange the material for destruction.

5.1.9 Any destruction of material shall be done in the presence of quality assurance representative.

5.2 HANDLING OF ONLINE REJECTION

5.2.1 Production manager or his designate shall in form to QA department about rejection of Packing materials during operation as per SOP Returning On Line Rejected Packaging Materials to Store.

5.2.2 Material shall be kept under hold with proper labeling.

5.2.3 QA department shall sample the online rejected material and submit to Quality control to perform testing (if required).

5.2.4 If rejected online packing material, does not comply as per specification then material shall be   transferred to rejected area of ware house and a copy of rejection note shall submit to account department.

5.2.5 If rejected online packing material, complies as per specification then Quality head and plant head shall be inform to take the necessary action.

5.2.6 In case of on line Bulk product rejection, does not comply as per specification then Quality head and plant head shall be informed to take the necessary action.

5.2.7 Finally Quality head and Plant head shall decide whether the material under question can be reprocessed and/or re- analyzed or to be destroyed.

5.3 DESTRUCTION PROCEDURE

5.3.1 Rejected foil (Aluminum foil /PVC), shall be destroyed by passing through shredder.

5.3.2 All printed packing material (excluding Aluminum foil) shall be destroyed passing through shredder.

5.3.3 Packed strip shall be de-foiled and tablet/capsule shall be crushed and shall be mixed in water and drain in ETP Plant.

5.3.4 Raw material and granules shall be mixed in water and drain in ETP Plant.

5.3.5 Plastic bottle shall be defaced with label and crushed by passing through shredder and powder is mixed in water and drain in ETP plant.

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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 tablets, Capsule, Liquid and Ointment.

5.2.2 These dried granules, Lubricated granules tablets, Capsule, Liquid and Ointment 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 PLASTIC BOTTLES AND TUBES:

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.

5.4.4     For 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, dull printing etc, in case of material rejections during usage such online rejections shall be returned to Warehouse 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 oi l /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 detailed procedure for dealing with batches to be reprocessed, reworked and repackaged.      

2.0 SCOPE:

Covers reprocessing, reworking and repackaging of Solid oral drug products manufactured

5.0 PROCEDURE:

No additional recovery is permitted for oral drug products.

5.1 FOR ORAL DOSAGE DORMS:

5.1.1 Reprocessing and / or reworking of an in-process material of an oral dosage form (drug product) shall be done as a result of deviation reporting, investigations thereof and procedure duly authorized by QA.

5.2 PROCESSING: Responsibility: production / QA / applicable cross-functional Heads or their designees          

5.2.1 QA shall ensure approval by the customers / contract givers / regulatory agencies prior to the   commencement of reprocessing. Refer to the technical terms of supply with contract givers and/or   commitments made in the relevant product applicable, where relevant.

5.2.2 Based on investigations arising out of OOS or OOT or Deviation and remediation proposal made      therein, the authorization of reprocessing shall take place through temporary change control.

5.2.3 The authorization for reprocessing shall consider the following:

• Regulatory assessment and / or notification (Where it is not permitted to proceed for the Reprocessing, unless obtaining prior approval from agency, the same shall be obtained prior to disposition of reprocess batch).
• Quality of finished product is not affected.
• Reprocessed batch meets specifications with additional testing, if needed.
• The processing steps are defined in a procedure and approved by QC / QA and Production.
• All risks have been evaluated, stability requirements, if any.

5.2.4 If trials are taken on part quantities, provide the observations or analytical results of the trials. The results shall be reviewed by QA. Details of such quantity used shall be recorded in respective BMR.

5.2.5 Samples of the re-processed batch shall be collected (if applicable, as determined in the disposition action) and submitted for stability studies (both accelerated and real time).

5.2.6 Document all actions taken in respective BMR. Attach a copy the completed investigation report in the BMR.

5.2.7 The reprocessed batch shall be assigned a with different batch number.

5.2.8 After reviewing the processes, analytical results and batch records, batch shall be released for distribution.

5.3 REWORKING: Responsibility: production / QA / applicable cross-functional Heads or their designees

5.3.1 Hold the product in appropriate area (temperature, relative humidity, secure) with its status label at relevant stage.

5.3.2 QA shall ensure approval by the customers / contract givers / regulatory agencies prior to the   commencement of reworking. Refer to the technical terms of supply with the contract givers and / or commitments made in the relevant product application, where relevant.

5.3.3 Based on investigation arising out of OOS or OOT or Deviation and remediation proposal made   therein, the authorization of reworking shall take place through temporary change control.

5.3.4 The authorization for reworking shall consider the following:

• Regulatory assessment and / or notification (Where it is not permitted to proceed for the reworking, unless obtaining prior approval from agency, the same shall be obtained prior to disposition of reworking batch).
• Quality of finished product is not affected.
• Reworked batch meets specifications with additional testing, if needed.
• The reworking steps are defined in a procedure and approved by QC/QA/ and Production.
• All risks have been evaluated including products stability requirements before release.

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PURPOSE

To provide the procedure to be followed for Continued Process Verification by Statistical Evaluation of data for Process Understanding and to improve process performance and product quality, if required.       

SCOPE:

This SOP is applicable for Continuous Monitoring of Manufacturing Process by the Statistical Evaluation of identified CPPs and CQAs for products manufactured at site.

5.0 PROCEDURE:

5.1 What is CPV?

5.1.1 Continued Process Verification is third stage of Process Validation. The goal of the third validation stage is continual assurance that the process remains in a state of control (the validated state) during commercial manufacturing. The assurance in this stage is achieved through collection and evaluation of information and data about the performance of the process, which allows detection of undesired process variability. This stage helps in evaluating the performance of the process, identifies problems and determines whether action must be taken to correct, anticipate and prevent problems so that the process remains in control. Continued Process Verification shall be performed after completion of the PPQ Batches.

This is the stage where process and analytical data of process validation shall be collected in Minitab work sheet and control chart shall be prepared for the for-process validation batches.

This is the stage where initial control chart of process validation is available and from the next batch onwards after the PPQ batch shall be monitored and the control chart will be updated using Minitab In this stage data shall be considered for statistical evaluation and inference. Any a typical trend in CPP which directly has an impact on the CQA and any atypical trend in the CQA will be investigated as per the OOT SOP.

• The 1^st process validation batches or the last successful revalidation batches shall always be part of the control chart.

5.1.2 Continued Process Verification shall be organized as below:

• Preparation of Protocol for Continued Process Verification by enlisting of CPPs and CQAs for Continued Process Verification.
• Collection and Statistical Evaluation of Data and preparation and approval of Continued Process Verification Report.
• Batch Release.
• Action to be taken when variation observed during data monitoring.
• Annual Product Review

5.2 Preparation of Protocol for CPV by enlisting of CPPs and CQAs for Continued Process Verification

5.2.1 For Every new Product, The CPPs and CQAs shall be provided by F&D based on product development, nature of product and criticality of product and process with justification or from the Process Validation Protocol / Engineering Batch Protocol.

5.2.2 Quality Assurance shall enlist the CPPs and CQAs of all products with the justification. The product CQA at finished stage shall be evaluated for continued Process Verification.

5.2.3 These listed CPPs and CQAs shall be considered for data collection and evaluation.

5.2.4 Quality Assurance person shall prepare and review of Continued Process Verification Protocol.

5.3 Collection of Data

5.3.1 After Completion of the manufacturing and packaging of the batch, the batch manufacturing record and packaging record shall be completed by the manufacturing personnel and same shall be reviewed and checked for compliance by IPQA Personnel.

5.3.2 The Batch Manufacturing Record and Packaging Record shall be submitted to the quality assurance department after reviewed by the IPQA personnel.

5.3.3 Before Submit of executed BMR / BPR Personnel from IPQA shall enter the values of CPPs and Process Yield from executed BMR and Personnel from QC shall enter the values of CQAs in worksheet using Minitab before release of the batch for commercial distribution.

5.3.4 For new drug product which is under process validation, the data shall be collected for validation batches. Once data for validation batches is available and control chart is prepared, statistical evaluations shall be carried out from the next batch onwards after PPQ batch.

5.3.5 For existing drug product, the data shall be collected for process validation batches with all commercial released batches irrespective of year manufactured except expired batches.

5.3.6 Data for the Continued Process Verification for CPPs shall be collected from the batch manufacturing / packing record by the IPQA personal and For CQAs from analytical reports for Finished Stage by Quality Control Personnel.

5.3.7 There are following preconditions shall be followed for calculation the control limit and trend the data:

• OOS batches shall be not considered for UCL and LCL calculation.
• Where special cause variations (Deviations, OOS, OOT etc.) are identified for specific batches manufactured, these values shall be removed from calculations for the Control Limits and Process Capability calculations.
• In above mentioned cases, identified batch data values shall be removed from calculations for Process Capability and Control Limits.

5.4 Statistical Tools, Interpretation and Statistical Evaluation

5.4.1 Control limit

5.4.1.1 The control limit is also known as the natural process limit, which are horizontal lines drawn on statistical control chart, which usually at a distance of ±3 standard deviations of the plotted statistic from the statistic's mean.

5.4.1.2 Control limit shall be calculated by using the Minitab or Manually by using Six Sigma (6s) approach as:

Upper Control Limit (UCL) = Xbar + 3s

Lower Control Limit (LCL) = Xbar - 3s

Where, Xbar = Mean and s = Standard Deviation

5.4.1.3 In Minitab the UCL and LCL shall be calculated automatically upon feeding the data in control chart. The statistical evaluation of the CPP and CQA shall be done as per the statistical tool define in Continued Process Verification Protocol.

5.4.1.4 For CPP and CQA which is having single side specification, the UCL and LCL shall be consider as below:

• Products having Upper Specification Limit: only UCL shall be considered
• Products having Lower Specification Limit: only LCL shall be considered

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PURPOSE

To define a procedure for review of audit trails for Electronic Data generated from software / process and utility equipment(s).

SCOPE

This SOP is applicable for review of audit trails generated by software associated with equipment used during manufacturing of products and utility (BMS, Water system, and Pure Steam, Compressed Air, Water for Injection etc.) and any other GxP software used in manufacturing, engineering, utilitie

5.0 PROCEDURE

5.1 Precautions:

5.1.1  Electronic systems should be configured to limit accesses and privileges to the authorized personnel ".

5.1.2 Date  and  time  modification of  a  computer  system / server system  should  be  locked  and controlled.

5.1.3 Audit trails of the electronic system should be enabled. Accesses of deactivation of the audit trail should be restricted to administrator only.

5.1.4 Delete rights should not be granted to any user / reviewer including system administrator if feasible.

5.1.5 User department shall identify the equipment which contains audit trail facility in software and maintain list. List shall be updated whenever addition or removal of any equipment annexure shall be used as template shall be dynamic in nature.

5.2 Prerequisites and overview of electronic audit trails:

5.2.1 System must be accessible to reviewer for review of electronic data of audit trail.

5.2.2 Audit trails are normally generated in the following two forms: however it depends on the functionality of software. 

• System Audit Trails:  System audit trails provide a trail of user access management related to creation, modification and deactivation/deletion along with changes in user privileges. System audit trails may also provide the details of system configuration. It also provides login- logout details of available users, logs related to back up activities, deletion of data and data import/export activities.
• Data Audit Trails: Data audit trails provide a trail of data generation, modification, deletion and record of system electronic data (including meta data) accessed and modified either by individuals or system (in built logic) during system operation. Data audit trail also include evidences of electronic signature if applicable in system.

5.3 Review of data audit trails before batch release to next processing stage:

5.3.1 Data audit trail shall be reviewed by user department and QA person before batch release for the next processing stage.

5.3.2 In other than process equipments like utility systems, BMS, Purified water generation and distribution system, etc. data audit trail review shall be done by the user department as per their respective SOP and by quality assurance person on a quarterly basis.

5.3.3 The original data or a true copy (preserving content and meaning) subjected for review. 

5.3.4 System generated printout (True copy) shall be validated to ensure that it preserve content and meaning of original data and print out report is generated automatically form equipment and cannot be manipulated. In such case review of system generated printout (True copy) is acceptable.

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