ORAL DOSAGE FORM SOPs

1.0 PURPOSE

To provide a procedure for preparation, review, approval, distribution and control of Standard Operating Procedure (SOP).

2.0 SCOPE: 

This procedure is applicable to all department standard operating procedures.      

5.0 PREPARATION PROCEDURE:

5.1 The format for the SOP structure is provided in (Annexure- I)

5.2 Use A4 size (Width: 8.40 inch and Height: 11.92 inch) white paper with JSA Logo (Height: 1.31 cm and Width: 3.81 cm).

5.3 Format the SOPs with following margins; Top: 1.2 inch, Bottom: 1.0 inch Left: 1.0 inch, Right: 0.5 inch, Header: 0.6 inch and Footer: 0.6 inch width with single line border.

5.4 Prepare SOP and its Annexure(s) in “Times New Roman” font with size of “11”.

5.5 Prepare SOPs in a clear, instructive, unambiguous, easy to understand and easy to follow language.

5.6 Include a list of abbreviations used in SOP.

5.7 Approve all SOPs prior to training.

5.8 Training and SOP effectiveness shall be done within 30 calendar days from the date of SOP Approval.

5.8.1 Each SOP shall have a header with following details.

ITEM - I:

Mention name of the company with font size: 11 in bold letter

ITEM - II:

Mention “Standard Operating Procedure (SOP) in Bold Letter.

ITEM - III:

Department: Mention initiating department for which SOP is being written. (Small alphabet).

ITEM - IV:

Title: Mention the title of SOP starting with word ‘Procedure for’ With small letter.

ITEM - V:

SOP No. Mention a unique number to each SOP. Each SOP number shall consist of fourteen characters, broken down as follows.

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1.0 PURPOSE

To provide a procedure for preparation of Validation Master Plan.

2.0 SCOPE: 

This SOP describes the preparation of Validation Master Plan

5.0 PROCEDURE

5.1 The Quality Assurance Assistant shall prepare Validation Master Plan.

5.2 Head Facility and Engineering, Head QC, Plant head and QA Head shall review and approve the VMP.

5.3  First page of the validation master plan shall contain document no, effective date and mandatory review.

5.4 Mandatory review shall be done at every three years from the issue date.

5.5 Numbering of the validation master plan shall be as XXX/001/R0 where XXX is refer to VMP i.e. validation master plan, Serial number and R0 stands for revision no since our present revision no is R0 so after this when revision is done No. changes to R1 and so on.

5.6 The header part contains

5.6.1 Name of company and location i

5.6.2 The name of document i.e. VALIDATION MASTER PLAN

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1.0 PURPOSE

To provide procedure for documentation, data entry and correction of documentation errors.

2.0 SCOPE: 

This SOP Covers all types of technical data recorded in documents and entry errors that could occur while entering data in different types of documents by all relevant functional departments 

5.0 PROCEDURE:

Good documentation is an essential part of the quality assurance system and, as such, should exist for all aspects of GMP.Clearly written documents prevent errors from spoken communication. The legibility of documents is of paramount importance to ensure the existence of documented evidence, traceability and to provide records and an audit trail that will permit investigation. It ensures the availability of the data needed for validation, review and statistical analysis. This guidance provides procedure for documentation. The SOP gives an overview of various types of entries done in all the quality related documents.

5.1 Types of documentation:

5.1.1 Commitment documents including the following but not limited to:

• Policies and guidelines pertaining to Quality.

• Validation Master Plan

• Registration documents

• Technical terms of supply

• Audit schedules

• GMP training plans

5.1.2 Directive documents including the following but not limited to:

• SOPs (e.g., Operation, cleaning, maintenance, calibration, etc.)

• Manufacturing (master formula records)

• Packing (master packing records)

• Approved artworks provided by customer

• Project drawings/drawing of customer & manufacturers

• Validation / stability protocols

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1.0 PURPOSE

To provide procedure for the preparation, review, approval and archival of a Site Master File to aid consolidated review of a manufacturing site.

2.0 SCOPE: 

This SOP applicable for the preparation of Site Master File         ​

5.0 PROCEDURE:

Data required shall be collected from cross functional teams by any suitable means to facilitate preparation of SMF.

5.1 Creation of SMF:

Prepare the SMF using the template for 'Site Master File’ as per procedure. Use Times New Roman font with font size 11 to prepare the document. Once completed, print the final copy of the SMF on a standard A4 sheets watermark with logo.

The approval page shall be signed by the authorized personnel.

5.2 Contents of SMF:

The Site Master File shall have the following contents as applicable, but not limited to:

5.2.1 Header:

The location name, city & country shall appear in the ‘Header’ section on every page of the document.

5.2.3 Footer:

The document number, effective date & mandatory revision of the SMF shall be entered in the ‘Footer’ section.    

5.2.4 Numbering of SMF:

The SMF No. is a unique alphanumeric code. The alphabetical part in the SMF number indicates the respective site/location to which the SMF belongs, followed by ‘/’ and the letters ‘SMF’ referring to Site Master File.

This shall be followed by the revision number of the SMF i.e., R‘XX’ where R refers to revision and ‘XX’ refers to the revision number/version number.

For e.g., JSA/SMF/R00 is the SMF number for the site ‘JSA’ (JSA Validation Services) bearing the version ‘R00’. Subsequent revision will bear the alphanumeric code: JSA/SMF/R00.

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1.0 PURPOSE

To provide a procedure for Document numbering of Qualification documents.

2.0 SCOPE: 

This procedure is applicable for numbering of all equipment qualification documents including production/QC/ facility and engineering equipment.    

5.0 PROCEDURE:

5.1 User Requirement Specification: shall have a unique number for identification as per following procedure

5.1.1 The first three character shall always begin with JSA followed by ‘/’

5.1.2 Next four to six character are stand for URS followed “/”

5.1.3 The next seven to eighteen characters shall be abbreviation of type of the equipment /system/instrument (e.g.’FBD’ for Fluid bed dryer).

5.1.4 If the equipment /instrument /system is rated for capacity, the same shall be donated by seven to eighteen character prefixed by ‘-’ (e.g. ‘-300 kg’ for  300 kg Fluid Bed Dryer or -600 Liter for Rapid Mixer Granulator)

5.1.5 The last two character shall be suffixed by ‘/’and donated by version number of URS such as   R0, R1, R2, etc. The version of the URS shall be changed if the content of URS (other than equipment type and capacity) calls for modifications.

5.1.6 Example of URS numbering for Fluid Bed Dryer which having a capacity of 300 Kg Capacity, the numbering shall be JSA/URS/FBD-300kg/R0 and for Rapid Mixer Granulator JSA/URS/RMG-600L/R0

5.2 Design Qualification:

5.2.1 The first three character shall always begin with JSA followed by ‘/’.

5.2.2 The next two character shall always be donated by DQ representing Design Qualification, and shall be followed by ‘/’.

5.2.3 The next eight to sixteen characters shall be abbreviation of type of the equipment /system/utility (e.g.’ FBD’ for Fluid Bed Dryer).

5.2.4 If the equipment/ utility/system is rated for capacity/speed, the same shall be denoted by two to six characters prefixed by ‘-’ (‘-300kg’ for 300 kg Capacity of FBD)

5.2.5 The last two characters shall be suffixed by ‘/’ and denoted version number of DQ such as R0, R1, R2, etc. Example: the DQ for Fluid Bed Dryer shall be given as JSA/DQ/FBD-300kg/R0.

5.3 Factory Acceptance Test:

5.3.1 The first three character shall always begin with JSA followed by ‘/’.

5.3.2 The next three character shall always be donated by FAT representing Factory Acceptance Test, and shall be followed by ‘/’.

5.3.3 The next Nine to seventeen characters shall be abbreviation of type of the equipment /system/utility (e.g.’ FBD’ for Fluid Bed Dryer).

5.3.4 If the equipment/ utility/system is rated for capacity/speed, the same shall be denoted by two to six characters prefixed by ‘-’ (‘-300kg’ for 300 kg Capacity of FBD)

5.3.5 The last two characters shall be suffixed by ‘/’ and denoted version number of FAT such as R0, R1, R2, etc. Example: the FAT for Fluid Bed Dryer shall be given as JSA/FAT/FBD-300kg/R0

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1.0 PURPOSE

To provide To provide a procedure for allocation of specific identification number to the Equipment or Instruments.

2.0 SCOPE: 

This procedure is applicable to all equipment and instruments present in the all Departments.  

5.0 PROCEDURE:

5.1 All the equipment shall have a unique number for its identification.

5.2 This equipment number shall be allotted at the time of receipt of that particular equipment / Instrument.

5.3 All numbers shall be given as per the following procedure.

5.4 The numbering system shall comprise of characters with alphanumeric symbols.

5.5 The first Three characters shall always being with JSA “JSA Validation Services” followed by ‘/’

5.6 The next two letter shall be written as “EQ”, for “Equipment” and “IN” for “Instrument” followed by ‘/’.

5.7 The next three characters shall be numerical which denotes the serial number of equipment/Instrument. This serial number shall start from 001 for the first equipment/Instrument ID no. request received by the Quality Assurance and for the instrument associated with equipment and identified during qualification start from 001.

5.8 For Example the equipment number shall be written as JSA/EQ/001 for the 1st equipment

5.9 The numbering for the Instruments shall be given as JSA/IN/001 for the 1st Instrument.

5.10 The numbering for the Instruments associated with equipment and identified during qualification shall be given as JSA/IN/XX/0001 for the 1st Instrument. XX stand for Instrument abdication like “PG” for pressure gauge, “VG” for vacuum gauge, “TS” for temperature sensor “MG” for Magnehelic gauge etc

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1.0 PURPOSE

To provide a procedure for reporting, investigation, review, approval and closure of deviations.

2.0 SCOPE: 

This procedure is applicable to deviations related to the following but not limited to:  

- Procedures, processes, equipment’s, utilities, material specifications or quality systems.

- Receipt, storage, manufacture and testing of materials, in-process products, finished products, drug product containers and closures.

5.0 PROCEDURE :

5.1 Initiation : Responsibility:   Any individual - for reporting the deviation.

           Respective department heads or designee - to review the deviations.

           QA  – numbering, logging and issuance of deviations report.

5.1.1 All the deviations shall be addressed through deviation report (Annexure-1). All deviations shall be reported and submitted to QA within 1 working day of its finding. Any late submission of event shall be justified by initiator.

5.1.2 Mention description of the event/ incidences in document which shall include following as applicable. When (stage/time), where (location /area/room no.), what (parameter out of limit/process not followed /followed wrongly/documented wrongly/any other), by whom (person involved if any), how (event/malfunction) seen/happened/ noticed and magnitudes (no. of units affected).

5.1.3 All the incidences shall be considered as deviations.

5.1.4 Deviation report forms shall be issued by QA to all applicable cross functional departments.

5.1.5 The deviations shall be initiated by any person/department that discovers/observe the deviations.

5.1.6 The person initiating the deviations shall fill section 1; ‘Deviation reporting’ in the deviation form (Refer Annexure I), and obtain the signature of the deviation owner or the department head, (department in which the deviation is observed).

5.1.7 Wherever appropriate, the deviation owner shall physically inspect or witness the area/product/material/process to understand the deviation for taking steps as defined in section 5.3 and onwards.

5.2 Deviation Logging :Responsibility: QA

5.2.1 Allot a serial number as follows: DR/001/2023 where ‘DR’ represents Deviation Report. ‘001’ represents first deviation during the year. ‘2023’ represents the last two digits of the calendar year in which the deviation is initiated (2023). (e.g. DR/001/2023 indicates the first deviation reported in the year 2023)

5.2.2 Log the details in the deviation register (Annexure-II) simultaneously.

5.3 Immediate action and assessment of deviation:Responsibility: Deviation owner/ HOD

5.3.1 Record the immediate actions taken upon observation of the deviation.

5.3.2 Perform an immediate assessment of the area, material and procedures and wherever appropriate, interview the people immediately associated with the deviation. HOD/Designee shall perform prelimnary investigation by using 5 why tool, other investigation tool as per SOP on investigation and determine the cause of deviation and the overall impact of the deviation on products quality.

5.3.3 Based on this information, record the following in the deviation form:

• Preliminary Investigation
• Cause(s) of the deviation if it is identified immediately
• Possible impact of the deviation on other batches / products / materials

5.3.4 HOD shall update outcome of preliminary impact assessment, impacted area, batch affected/impacted, affected/impacted batch No., risk analysis and evaluate root cause as assignable/probable

5.3.5 Propose the resolution actions for the affected materials, batches, etc based on the preliminary findings. If required, the deviation owner may propose to carry further products/materials investigation for recommending the remedial actions.

5.3.6 Forward the deviation forms to QA for further assessment.

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1.0 PURPOSE

To provide a procedure for making temporary and permanent changes, which include initiation, evaluation, review, impact assessment, risk assessment, categorization, list out of action items, approval /rejection of the proposal, Implementation of the approved change, effectiveness check, Post implementation and closure of the change control. This is to ensure that change(s) have no adverse implication on quality, safety, efficacy of the product, and regulatory requirements.

2.0 SCOPE: 

Change control procedure(s) to be followed for changes to specification, processes, equipment(s), utilities or systems etc.

5.0 PROCEDURE:

5.1 Before initiation of any change provide detailed information regarding the change to QA head / designee, then QA shall review the proposed change and if QA find that the proposed change is acceptable and satisfactory for implementation then approving change control form given to initiator for initiation.

5.2 Initiator shall fill the following information in the ‘Change Control Form’ in “section 1.0”, Refer Annexure-1.

5.3 Mention the name of initiator and his/her department, date of initiation and related category of change.

5.3 Mention the market(s) affected by the change and specify the customer or contract giver, if applicable.

5.4 Identify the purpose of the change(s) from the given options, and tick the relevant option for indicating the area the change is related to.

5.5 Mention the name of the product/material/equipment/system/document and its code/number for which the change is proposed.

5.6 Write brief description of the current status, proposed change(s) and justification(s) of the change. The justifications should include the following but not limited to:

• Data justifying change.
• History of successful temporary changes and its references.
• Trend analysis of relevance.
• Details of trials performed.
• Regulatory or standard references.
• Validation data.
• Any suitable justifications which are science based.

5.7 Identify the type of change(s) whether the proposed change is temporary in nature or permanent. Temporary changes should be initiated in the conditions mentioned below:

• The proposed change is temporary in nature (the reinstating date/period to previous state is known or projected).  A repeated pattern of temporary changes for same reason is assessed for its potential risk on product quality prior to approval of such change.
• ‘Temporary change’ is used for data capturing / validation for regularizing in future
• Exceptional cases, where established procedural requirements can be waived based on substitute action plan, subject to cross functional review and acceptance, and regulatory approval wherever applicable.

5.7 Identify the training needs, and the target people / groups, where applicable.

5.8 If required structured risk assessment (e.g. FMEA) shall be performed for change control as per standard operating procedure Titled “Quality risk management”

5.9 Change planning, prioritisation, implementation, and their timelines shall be based on risk assessment.

5.10 The originator shall do the preliminary assessment of the change proposal and shall attach action plan based on requirement and nature of change proposed.

5.11 Mention Target date of implementation of the change (Closer of All action items).

5.12 Initiator shall sign and forward the Change Control Form to his/her HOD to check the filled information about the change.

5.13 The department head shall review the change for its requirement, necessity, and appropriateness of the justification and approve or reject the Change Control Form (Section 1.0) with signature for further processing.

Note: Identify the Cross functional department required to evaluate (perform impact assessment) and indicate the relevant tasks associated with the proposed change.

5.14 Then the initiator shall submit the Change Control Form approved by the department head to the Quality Assurance.

5.2 Change Control logging:                                        Responsibility: Quality Assurance

5.2.1 After logging change control allot a serial number as follows: XX/ZZZZ/NNNN where:

‘XX’    denotes TC for temporary change or PC for permanent change.

‘ZZZZ’ denotes serial number for change control starting from 0001 for the respective type of change.

‘NNNN’ denotes the four digits of current year.

Example:  For both Temporary and permanent change control number is different as follows,

The first temporary change for the year 2023 is numbered as TC/0001/2023 and PC/0001/2023.

5.2.2 Identify the additional departments / stakeholders (if any) who shall be required to review and identify the tasks for accomplishing the proposed change. The identification of stakeholders shall be done as per the category (i.e.) the change is related to identify whether the change control requires approval or concurrence from customer / contract giver. If approval require from the customer/contract giver notification/change control form shall be send to them by Scan Copy, mail, by Fax and their comments shall be recorded in the change control form and a copy of scan form, mail, fax with their comments shall be recorded in the change control. 

5.2.3 Quality Assurance will send the copy of the Change Control Form to the initiator for organising the cross functional department coordination meeting for assessment of impact of change on various systems, areas, etc.

Note: The concerned department shall assess the proposed change and comment on the actions/reviews arising out of the change control.

5.3 Impact assessment :                                       Responsibility: Change Initiator, QA

5.3.1 The Quality Assurance will assess the initiated change control form along with the details, as required. If any information is inadequate or any modifications are required, the form shall be sent back to the initiator.

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PURPOSE

To provide the steps to carry out an investigation using suitable investigation tool and scientific rationale to identify the root cause.

SCOPE: 

This SOP is applicable to all the investigations carried out related to but not limited to, Market Complaints, Deviations, Product Recall, Returned Drug Products.

5.0 ROCEDURE:

Any investigation arising through any of the QMS described in the scope shall follow the steps mentioned below:

5.1 Formation of CFT Team:

5.1.1 Impacted department or personnel identifying the non-conformity shall notify QA within one working day to initiate investigation within timely manner.

5.1.2 Investigation shall be initiated by investigator (impacted department/Quality assurance.

5.1.3 A cross functional team (CFT) shall be identified by the head of the impacted department Quality Assurance department.

5.1.4 Based on the nature of investigation the team members shall be selected who shall be Subject Matter Experts on process, equipment or system under evaluation. A lead investigator shall be identified from CFT. The Head of impacted department/QA shall ensure that the investigation is completed within the defined time line.

5.2 Historical review (Recurrence):

5.2.1 Investigation shall include historical review of (a) similar nature of event reported in same product and product group in past two years (b) similar nature of event reported in other product group in past two years. Review shall also extended to all batches/ product manufactured in the premises equipment  and system indicating similar root cause identified and implementation of CAPA actions for similar event shall be evaluated.

5.2.2 The data of corrective / preventive action shall include the date of implementation with current status.

5.2.3 Historical review of the events shall be listed to understand whether similar nature of events occurred previously and if yes whether CAPA proposed is implemented. This shall help in defining the investigation approach.

5.2.4 Historical review should also be correlated, once the root cause is identified and concluded for repetitiveness and for any additional actions, if any.

5.2.5 The inferences of historical review shall include:

• Details of previous CAPA’s and its implementation status
• CAPA effectiveness review check (as applicable)
• Instances of similar events after implementation of previous CAPA

5.2.6 Historical event shall evaluate the recurring issues, recurring root causes, and secondary issues.

5.3 Investigation Plan

5.3.1 General flow of investigation is outlined in Annexure-I (QAD/087/F-01

5.3.2 Wherever required, QA shall be responsible for initial categorization of events (Deviation) (i.e. Critical, Major, Minor) as applicable. Post investigation categorization of events shall be again evaluated by QA head for finalization. Post investigation categorization shall be considered as final for further action.

5.3.3 On identifying the need for investigation the investigation plan shall be prepared. Depending on the nature of investigation a protocol based investigation may be executed.

5.4 Preliminary impact assessment and immediate action:

5.4.1 An immediate action shall be taken if required and a preliminary impact assessment shall be done (vertical and horizontal) using existing data available.

5.4.2 Immediate action may include identification, segregation or quarantine of the affected system, products and lots (both pre and post event including marketed). Quarantine of product (s) already released batches and processing the batch to the next logical step, containment of area and equipment. 

5.4.3 Management shall be notified if any impact identifies regulatory action such or product recall based on preliminary impact assessment.

5.4.4 Circumstantial evidences shall be collected to conduct an investigation. If necessary, photograph shall be taken to facilitate the investigation. 

5.5 Investigation approach to identify root cause:

5.5.1 Investigator shall conduct interview of all relevant operators, supervisors and any other personnel involved in the event. “5 why” technique for the interview of personnel shall be followed. A documentation of such interview shall be recorded in sheet and put along with the Investigation Report.

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1.0 PURPOSE

To provide the procedure for the document and monitor corrective and preventive actions resulting as an outcome of investigations, assessment, reviews and audit/inspection observations.

2.0 SCOPE: 

This procedure is applicable to all actions initiated as part of the recommendation from QMS elements as listed below and subsequent investigation(s) arising out of various quality system for the purpose of either identifying the cause(s) to avoid the failure or to avoid the recurrence of the failure or to avoid the occurrence of any potential failure

QMS elements triggering CAPA:

• Complaint Management
• OOS
• Recalls
• Deviations
• Regulatory inspection
• Process performance trends and Product Quality Reviews
• Quality Risk Management
• Improvement Plans
• Quality System Review
• Audits (Regulatory / Customer / Internal)
• Validation / Qualification

Root cause Investigation is shall be done through the SOP No. JSA/SOP/QA/009, Titled “ Procedure for Root Cause Investigation”

5.0 PROCEDURE:

5.1 A CAPA is to be initiated as an outcome of an investigation or root cause analysis of audit/ inspectional observation from a given site or other sites.

5.2 QA shall add CAPA arising from learning from regulatory / external SME inspection at other sites, regulatory inspections reports of other Pharmaceuticals company, publication of new guidance /directives etc. The need of CAPA initiation shall be identified through any of the following system but not limited to:

• Complaint Management
• OOS
• Recalls
• Deviations
• Process performance trends
• Product Quality Reviews
• Quality Risk Management
• Quality Review Program
• Improvement Program
• Investigations report
• Other initiatives

5.3 Quality assurance shall ensure that CAPA is initiated and approved prior to the batch disposition.  

5.4 The CAPA procedure is applicable at all the stages of product lifecycle with procedure as shown below:

5.5 Initiation 

5.5.1 CAPA shall be initiated for identified root cause or most probable root cause and by the person/department (CAPA owner) that shall be responsible for leading the investigation efforts and implementation of CAPA arising out of the investigation. CAPA owner may involve other functions for investigations and CAPA.

5.5.2 The CAPA owner shall fill the section of ‘Initiation’ as per annexure 1 with the below mentioned details:

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