SOP ON SOP In Pharma

SOP ON SOP In Pharma

PURPOSE: To describe a procedure for preparation, review, approval, revision, and control of Standard Operating Procedures and General Test Procedures.

SCOPE: Applicable to all Standard Operating Procedures and General Test Procedures.

RESPONSIBILITY:

Author/ Initiator of respective section shall be responsible for preparation or revision of SOP & GTP.

Shall be responsible for sending document for review and signature.

Shall be responsible for follow-up of the entire process of document lifecycle.

Shall be responsible for recall of controlled copies of older version of SOP’s & submit the same to QA before making document effective of subsequent version.

Reviewer of respective section shall responsible for reviewing the document in terms of necessity, benefits, effectiveness, viability and regulatory compliance.

Shall ensure the adequacy and accuracy of the document content and supporting references.

Shall ensure timely implementation of approved document.

Approver (Quality Assurance) shall be responsible for Technical approval of documents.

Approver shall assess the requirement for document and review technically as subject matter expert.

Quality Approver (Head / designee QA) shall responsible for final approval of documents

Shall be accountable for effective implementation and compliance of procedure.

Document Coordinator (Quality Assurance):

Shall be responsible for making document effective.

Shall ensure retrieval of earlier version of document.

Shall be responsible for issuance & distribution documents.

Shall be responsible of issued document reconciliation.

Shall ensure timely implementation of approved document.

Shall be responsible for update/ release training in the OMS.

Shall be responsible to update applicable sites (for corporate documents).

Shall be responsible to export master Index as and when required.

DEFINITIONS:

Standard Operating Procedure – SOP is a set of written instructions that document a routine or repetitive activity followed by an organization.

General Test Procedure: A controlled document, which shall define general test methodologies for testing of materials. These procedures are generic rather than product or material-specific.

Documents: A piece of written, printed or electronic matter that provides information or evidence or that serves as an official record. For example: Batch Records, Operating Procedures, Specifications, etc.

Effective: This state indicates that this version of a document is current and is in use in the site or organization.

Next Review Date: The date before that a controlled document shall be reviewed for revision and the document shall not be used beyond this date as an official document.

Template: A controlled document used to convey reference information, or designed to allow the recording of data to prepare documents in a standard layout.

Superseded: Historical versions of official electronic documents that have a newer version in effect.

Withdrawal: Historical versions of official electronic documents that are no longer in use. Withdrawn is typically synonymous with “Obsolete”.

Suspended: Versions of documents that are temporarily out of use.

Master Document: The original approved document which shall be retained and which can be used for making further copies for routine use.

Controlled Documents: A controlled document is a reference document that through the course of its lifecycle may be reviewed, modified, and distributed several times. A controlled document shall be officially tracked, updated, and stored for use.

Controlled Copy: A copy of Master Documents for which issuance and retrieval are tracked. A controlled copy document is the latest version of the document and when a change is made, it is retrieved and replaced with the revised version.

Uncontrolled Copy: Document for which maintenance, storage, security, and destruction are not defined and need no updation.

DMS: It stands for Document Management System for initiation, execution, review, approval, usage, and retrieval throughout the document life cycle.

PROCEDURE:

Each SOP/ GTP shall contain the following information:

PURPOSE: Outline the objective or intention of the SOP /GTP.

SCOPE: Outline the equipment, area, department, facility, system, and test to which the procedure applies.

RESPONSIBILITY: State the department/personnel responsible for performing the activities required by the SOP/GTP.

DEFINITION: State the meaning of the unique term/s used in the procedure.

PROCEDURE:

The procedure shall be written in a concise, step-by-step, easy-to-read format with caution, notes, and other instructions if any.

In general, the procedure shall be in the English language, however, if there is a specific requirement, the procedure may be written in vernacular language.

Use simple, unambiguous, and meaningful short sentences.

The step-wise analytical test procedure shall be written in the instructional form to with caution, note, instruction, and the instrument used if any.

Wherever necessary pictorial representation/flow charts shall be included.

SOPs shall be written by individuals knowledgeable about the activity and the organization’s internal structure. These individuals are essentially

Subject-matter experts who actually perform the work or use the process.

SOPs should be reviewed by one or more individuals with appropriate training and experience with the work or process.

Any document required for recording information such as form, format, checklist etc. shall be attached to the SOP/GTP as Form. Such Forms shall be numbered.

ABBREVIATIONS: The full form/s of the short form/s used in the SOP/GTP shall be mentioned.

REFERENCES: The number and name of the SOP/GTP without version number or the names of any other guidance books /operational manual required to be referred shall be mentioned.

ANNEXURE / FORM: The number, name and type of the applicable Forms of the procedure shall be stated. Term Form is used in OMS application and Annexure in Manual documentation.

REVISION HISTORY:

Revision history page shall have columns such as the version number, Effective date (for manual documentation), Reference document number/

Change control number and the details of review / revision of the SOP/GTP in a chronological manner.

Training for new / revised SOP shall be mandatory and for GTP it is not mandatory.

All site specific SOP/GTP shall be made effective within 30 days from date of approval. SOP/GTP applicable for multiple sites shall be made effective within 60 days of approval.

The Corporate document shall be implemented as such at manufacturing site.

If required, Site specific SOP/GTP can be made, if there is a requirement of site specific changes. Whenever site specific SOP/GTP is made, the

Corporate document shall be used by site QA for guidance.

In case, Corporate SOP/GTP are not available for any topic, site specific procedure can be made.

Creation & revision of SOP / GTP through Documentum (DMS)

Respective department shall evaluate the need of required document and draft the same using OMS application.

Documents shall be reviewed by cross-functional team as applicable.

Document Number: Each SOP /GTP and Form shall have unique document number generated through OMS:

Document Creation:

An authorized user with author role shall login to OMS application to create a document.

Author shall be allowed to create only those document types for which they are authorized at applicable site.

Author shall enter/select all metadata related to the respective document type in each tab named Classification and Traceability as applicable (e.g. Document Title, Applicable Areas, Subgroup, Sub Department, Sub Department Code and Pharmacopeia Name etc.).

Training shall be mandatory for SOP Document type and by default selected as “Yes”.

Training shall not be mandatory for form & GTP Document type and by default selected as “No”.

Author shall select the initiating department and quality assurance department in applicable area field. However, the selection of other departments shall be based on the responsibility defined in the document.

For “Form” type of documents, New / Revise Reason field under the traceability tab shall be mandatory and author shall maintain the revision history of the document in this section.

Author shall enter QMS document number in quality record number under traceability section and it shall be mandatory in case of revision of document.

A pre-defined OMS template shall be used for the creation of a document for respective / selected document type. After entering the mandatory field details, a predefined template based on the document type selection shall be opened.

Author shall draft the document based on the requirements by entering details in respective sections of the template.

Author shall not change any auto populated values in header or footer section of the template. However, layout of the “Form” template can be modified from default portrait layout to landscape layout, if required.

Document shall be saved during ‘Check out’ at system default folder path and upon check-in, document shall be moved to the OMS application by default.

Do not leave the OMS application without saving and check-in/Cancel checkout the document.

Based on the input data in document properties and user profiles, folder shall be created by system default and document shall be saved in that specific folder.

Following folder Structure shall be available in OMS system for document tracking and display for SOP and Form types of documents;

Company Database

Governance and procedure

Site Name

Document Type (e.g. SOP/Form)

Initiating Department Name (E.g. CQC)

List of all Documents

Following folder Structure shall be available in OMS system for document tracking and display for GTP types of documents;

Company Database

Governance and procedure

Site Name

Document Type (e.g. GTP)

Pharmacopeia Name (E.g. USP)

List of all Documents

Wherever, Form (Annexure) are applicable in particular SOP/GTP document, the same shall be linked with respective SOP/GTP before sending for review. Relation type shall be selected as ‘Related Form’.

In case relation is being created by selecting SOP/GTP document than check box for ‘Reverse Relation’ shall not be tick marked.

Whenever a new document is generated in the system, it shall be assigned with version 0.1. Each time the same document is edited and “Checked in”, the version shall be incremented to the next minor version (e.g. 0.2, 0.3 and so on). The first Approved version shall be the major version i.e. 1.0.

During revision of an effective version, for example version 1.0, the next minor version shall be assigned as 1.1 · and incremented to subsequent number at each time the same document is edited and “Checked in” (e.g. 1.2, 1.3, and so on). Upon approval of document, version shall be incremented to the next major version i.e. version 2.0.

While revision of SOP/GTP document, if related Form does not have any changes then Form shall not be initiated for sign off. However, if there is a change needed in related Form then respective SOP/GTP shall also be revised and initiated for signature workflow.

System generated email notification shall be triggered to respective users for task assignment at various stage of document life cycle. If task is pending at a specific level, then overdue notification shall also be triggered and escalated to next level.

Document Collaborative Editing (Drafting Document) Workflow:

The author shall send the draft document for Collaborative Editing and Review to the responsible cross-functional stakeholders by selecting related Form (As applicable).

Where a document is applicable to multiple sites, reviewers from respective sites shall be selected.

Option, “Review and Edit Consolidated Copy” shall be selected while collaborative review and editing.

Reviewer shall edit or review document in “Draft” copy. The document shall remain in “Draft” status during Collaborative review.

Once reviewer completes editing of Document, then document shall be “Checked in” into OMS application.

Once all stakeholders complete their review of the document, the author shall consolidate all comments and review for incorporation or rejection in consultation with the reviewers.

When required, the document author shall send the draft document for an additional collaborative review or end the collaborative editing workflow.

If required, the author shall create the next minor version of a document and start Collaborative review workflow.

Author must accept Track change before sending the document for review and approval workflow.

In specific documents where document does not require review from cross functional team then collaborative edit workflow shall be optional.

In case document sent for collaborative review and editing to those users whose review is not applicable/not required then collaborative review and editing workflow shall be aborted with justification.

Document Review and Approval Workflow:

Before sending the document for “Submit for Review and Approval” workflow, all related task of “collaborative and editing” must be completed by all stakeholders.

The author shall start the Review and Approval workflow for electronic signature.

Related Form (Annexure) shall be attached with respective SOP/GTP while sending the document for Review and Approval electronically.

Once document shall be send by author for review and approval, then document shall be available with respective reviewers and approvers sequentially.

Reviewers & Approvers shall have option to return the document with comments for any amendment / correction. If any Reviewer / Approver rejects the Task, the document shall be moved back to Author in “Draft” status.

Respective reviewer and approver shall review the document and sign off electronically.

Finally, Head/Designee-Quality Assurance as Quality Organization approval shall electronically sign the document.

Upon approval of Head/Designee-Quality Assurance, document shall be available with Document Coordinator for acceptance and initiating necessary actions e.g. Training and/ or Making document effective.

Upon acceptance from Document Coordinator, document status shall be updated to ‘Release Pending’ and considered as ‘Approved’.

Version number of document shall be updated to major version e.g. 1.0, 2.0 etc.

Making Document Effective:

In case training is required for the document then Document Coordinator shall export the document and hand over to Training Coordinator (Person who coordinate the training) to carry out the training as per respective procedure.

In case of corporate documents (e.g. Corporate SOP’s etc.), Corporate Document coordinator shall export the document and hand over to Site

Training Coordinator to carry out the training at respective site as per respective procedure.

Document coordinator shall release the training and after completion of training, document coordinator shall complete the training.

Upon successful completion of training, Document Coordinator shall complete the training task in the OMS application and make the document effective.

In case of corporate documents, site training coordinator shall share the training status to document Coordinator. Document Coordinator shall complete the training task in OMS application & make the document effective.

Author shall initiate recall process (Retrieval) for controlled print copies of previous version, if applicable. Accordingly, document shall be made effective as per requirement.

Where, training is not applicable Document Coordinator shall make the document effective as per requirement i.e. Make effective immediately.

Whenever there is a need for correction in an approved document, the document shall be edited by author as “Draft” status with an increment of next minor version e.g. 1.1 and routed through respective workflow cycle/QMS procedure, as applicable.

The document shall reflect in “Doc list” of OMS application and shall be displayed to authorized users.

Document status (e.g. Draft, For Review, For Approval, Release Pending, Effective, Superseded etc.) shall be displayed diagonally on the document while display or printed copy, as applicable.

In case of revised document made effective then earlier version of document shall be made ‘Superseded’ by system automatically.

Next Review Date to each document shall be assigned by default as 3 years by calculating from the effective date e.g. if document made effective on 01-02-2024 then ‘Next Review Date’ shall be as 31-01-2027.

Site Implementation procedure:

Applicable Effective Documents shall be implemented at other sites e.g. Corporate documents (SOP’s) and/ or ARD document (GTP).

Document Coordinator of originating site shall update the required site name in ‘Update Applicable Site’ field where document is required to be implemented.

Update Applicable Site shall be done at all applicable site simultaneously.

Once the document is implemented at site then Site users can view and access the implemented document.

Document Withdrawal (Obsolete):

When the Change Control is approved for withdrawing a document from the system, the Coordinator shall start the Withdrawal workflow as mentioned below.

Login with coordinator user credential.

Select the document, right click, click on ‘Launch Withdrawal workflow’ and Enter/Select the withdrawal approver, and click ‘OK’ button.

Logout as coordinator and login with approver user credential.

Click on task tab and from the “workflow task list” widget, locate and click the document required for withdrawal task.

Right click on the existing document task and select the “accept task” from the menu list from the pop up window, enter comment and click ok on “forwarding task’ document required for approval for withdrawal properties windows and click on ok.

From the ‘Forwarding – Sign off of ‘document’ popup window, enter/select

Login details, password and intention of withdrawal.

Click on ok button.

Required approval task shall be removed from “workflow task list”.

Upon approval, document shall be withdrawn.

Document Suspension:

If required, an effective document shall be moved to a temporary suspension status by a Coordinator. During suspension status of the document, document shall not be used.

A suspended document may be either revised to the next version or withdrawn from the system or can be made effective again as per requirement.

For suspension of document click on Doc List option, right-click on a document in the Effective or Approved state, select Suspend document, and click ok.

To reinstate the document, select Reinstate as “Effective/Final” version.

Document Periodic Review:

Periodic review workflow shall start 60 days prior to ‘Next Review Date’ of document and Document Coordinator shall receive a system notification for periodic workflow initiation and send task. The Document Coordinator can also manually initiate the periodic review workflow.

The Coordinator shall select the Reviewer for the revision of the document.

Reviewer shall decide whether document need revision or no revision required.

Upon final decision from reviewer, if no revision is recommended then New Review Date shall be extended to system default date i.e. 3 Years. In this case, Document Coordinator shall initiate Recall process (Retrieval) for controlled print copies having old ‘Next review Date’, if applicable.

In case, revision is recommended and author shall revise the document as per procedure. Author shall acknowledge the “Request for revision “task for the document. The next minor version of the document is created in “Draft” status and is available for revision and Document Creation /Revision workflow shall be followed.

Note: Periodic Review may be started on the effective document any time within the document lifecycle, but the revised document must be “Effective” by the Review Due Date.

Controlled Print of Document and Recall:

Document Coordinator shall print the document as a controlled copy by using Controlled Print Services.

Document Coordinator shall print Master Copy for business continuity plan.

The watermark, caution statements and configured metadata (as applicable) shall be automatically populated on the printed copy.

In case, a miss-print / damaged print / printout not generated through printer, then re-print of “Controlled Copy” shall be taken and unique Re- .print identification number shall be printed on Controlled copy.

Controlled copy shall be issued to users and require Recall (Retrieval) upon Document withdrawal or Version is Superseded.

Recall of Controlled / Master Copy shall be started for Superseded /obsolete version of documents after new version of a document becomes effective or the existing version is made obsolete in the system.

Respective user(s) shall ensure the return of the superseded / obsolete controlled copy to the responsible person and complete the Recall task in the system.

Issued Print (Issuance) of Document and Reconciliation:

Document Coordinator Authorized personnel shall print the document as an issued copy by using Issued Print Services and assign the reconciliation date.

Issued print shall be used when document shall be used to fill information in prescribed form.

The watermark, caution statements and configured metadata (as applicable) shall be automatically populated on the printed copy.

In case, a miss-print / damaged print / printout not generated through printer, then re-print of “Issued Copy” shall be taken and unique Re-print identification number shall be printed on Issued Copy.

Issued print copy shall require reconciliation upon Document execution is completed. Authorized users shall reconcile the issued document in OMS application.

Export and Uncontrolled Print:

Document Coordinator shall export a pdf copy whenever required.

Document Coordinator shall print ‘Uncontrolled Copy’ whenever required.

Uncontrolled copy shall be valid for 7 days from printing date.

The watermark, caution statements and configured metadata (as applicable) shall be automatically populated on the printed/exported copy.

Document download permission is restricted to authorized users only.

System shall display message as ‘Download Restricted’ to users other than authorized users. User can view the document in ‘Brava Viewer’ only.

For detailed operational procedure of OMS application, “Operation Procedure in OMS Application”.

In Documentum application, format no shall be displayed as OMS template no.

Documents details e.g. Document Number, Title of Document, Effective Date and Next Review Date can be exported from the OMS application for preparation of Master Index.

For logbook preparation of forms “Issuance and control of logbook” or site specific procedure.

Procedure for Handling of Document during DMS Application Downtime:

In case of OMS downtime, documents shall be prepared and handled through manual system, irrespective of the stage of the document in OMS.

Same document number as generated through OMS shall be used for manual documentation. In case of new SOP/GTP next document number as per OMS index shall be assigned.

Upon resume of OMS Application services, manual process of documents shall be stopped irrespective of the stage and shall be proceed in OMS application by referring the document number.

Processed document through manual system shall be submitted to QA as per relevant procedure.

Document number and reason for OMS downtime shall be mentioned in manually processed document.

Manual Procedure for SOP/ GTP preparation, revision and control:

All document shall be prepared as per details of format

All SOP / GTP and its associated Annexure shall be prepared

HEADER OF FIRST PAGE:

The header of the first page shall be prepared as given in the layout. The company logo shall be at the top left corner and the name of manufacturing site (Location) to be at the top right side. User department name shall appear at the top right corner of the SOP/GTP.

The title of the document is to be descriptive but brief and must address specific equipment, products, process, activity or system. No abbreviated forms will be used in the title of the document.

Each SOP /GTP and Annexure shall have unique number.

The version number of the superseded document must be indicated. It shall be ‘New’ for first issue of the SOP. In case of merger of several documents, indicate the SOP/GTP nos. of the earlier SOP/GTP along with their revision numbers.

Effective Date: This column shall indicate the date from which the SOP/GTP is implemented. The effective date shall be stamped or hand written in black / blue color permanent ink in the XX/MM/YYYY or XX/MM/YY or XX-MM-YYYY or XX-MM-YY format.

Review Date: The review date shall be 3 years from the effective date of the SOP/GTP, or unless otherwise any change in procedure. The document shall be reviewed within – 60 days from its review period.

The individual page number and the total number of pages of the SOP shall be indicated in the right side of the header (excluding the Annexures), e.g. X of Y format where X is the individual page number of the document and Y the total number of pages in the document.

CONTENT OF FIRST PAGE:

First page shall have the table for signatories of the SOP /GTP as details below:

Prepared by: The person who has prepared the document shall write the name, Designation, Department and then sign in black / blue permanent ink.

Reviewed by: The heads of user department or designee. The person who has reviewed the document shall write the name, Designation, Department and then sign in black / blue permanent ink.

Approved by: Head QA or designee shall approve the SOP/GTP shall write the name, Designation, Department and then sign in black/ blue permanent ink.

Note: The names, department and designations can be pre-printed or handwritten.

The header of subsequent pages of the document shall be the same as the header of the first page except that it will not have the columns of “Effective date” and “Review date”.

The footer of subsequent pages of the document shall have the signatures of the personnel preparing and reviewing the document along with date.

The signatures of reviewers and approvers can be more than one as required.

The effective date shall be “hand written or stamped in DD/MM/YYYY or DD/MM/YY or DD-MM-YYYY or DD-MM-YY format”.

Content of Annexure:

The header shall have company logo on left hand top corner of each page of the Form.

The first Annexure of any SOP/GTP shall be numbered, followed by the document number without the version number on the next line at the top centre of the header of page.

This shall be followed by the title of the Annexure in the centre.

The page number/s for the Annexure/s shall appear at the bottom centre of the footer of each page as X of Y i.e. If Annexure is of two pages then pages should be numbered as Page 1 of 2 and Page 2 of 2.

The format number shall appear at the bottom right hand corner of the footer of each page of the Annexure.

The Annexure shall be signed at the bottom of each page for the signatories signed in the document as prepared by and reviewed by.

Procedure for New SOP/GTP preparation: Each SOP/GTP shall be written, edited, approved, circulated and withdrawn as follows:

The user departments shall identify the areas in which the document are to be generated and get document number from QA.

The person responsible to prepare the document shall first make a draft copy of the document in the format indicated above with the word

“DRAFT” mentioned on each page.

The draft document shall be circulated to all the concerned department for review.

The draft shall be reviewed by the concerned departments for suggestions and revisions as may be required.

After receipt of comments and suggestions appropriate update shall be made to new issue of the document.

Colour master copy of the document can be printed using appropriate software and hardware as required.

After the preparer sign, send document to the reviewer for signature and then to the respective department head and QA department for approval as relevant.

After approval of the document the original copy shall be stamped as ‘MASTER COPY’ at the top centre of the document in the space above the header on all the pages of the document by the QA department.

The master copy of SOP/GTP shall be given to the user department for conducting training of concerned personnel to make them aware of the changes in the document.

After completion of the training the SOP shall be handed over to QA department. Effective date shall be stamped or hand written in blue/ black color permanent ink by QA department.

QA department shall retain the master copy and update the Master SOP index.

In case of Corporate SOP/ GTP the original copies shall be kept with Corporate QA /DQA and non-editable electronic copy in the form of PDF file shall be send to respective site QA.

Site QA department shall take copy of the electronic version of Corporate document and stamp it as “CONTROLLED COPY” at the bottom of the first page.

The controlled copy stamp shall contain the following details: Accepted by (Sign & Date)/ Date of implementation.

Site QA shall ensure that whenever a revised document is issued, all the earlier versions of the document available in the plant are destroyed. A record of issuance and destruction shall be kept by site QA.

Whenever corporate document is implemented at site as such, then after completion of necessary training, implementation date at site shall be marked by site QA in the controlled copy stamp.

In case, the corporate document is taken for guidance, then, “For Reference” would be put against “Date of Implementation” column in control copy stamp.

The originally stamped copy shall be considered as master copy for site QA & controlled copy of the master copy shall be distributed to the applicable departments of site.

The controlled copy shall be handed over to the user department.

New / revised SOP/GTP shall be communicated to QA at all sites whenever they are released for implementation.

Whenever corporate procedure is revised, site QA shall evaluate these changes in corresponding site procedure and effect necessary changes in site specific procedure in-line with the revised global procedure.

REVISION PROCEDURE FOR EXISTING SOP/GTP:

The user department shall identify the revision/s required, edit the SOP/GTP, circulate the draft to the concerned and obtain the feedback along with change control.

Based on the feedback from concerned departments the user department shall prepare the final version of the revised SOP/GTP and proceed for review & approval.

Any revision in the existing procedure shall be done by giving the subsequent revision number.

In case there is revision only in the format and no change in the SOP/GTP contents then along with the change in the format number, the procedure shall also be changed with a new version number.

In case there is no revision in the format and change in the document contents then the format number will remain the same. The document shall be changed with a new version number. The Annexure will be reprinted with the same format no. and signed off with new date. In such cases the formats will be continued with the earlier version.

The “Revision History” page shall briefly indicate the changes made in the revised document.

The revision history page shall be a part of the SOP/GTP.

A Master index of all current document used within the site shall be maintained by the QA department. I.e. Document Number, Title of document, Effective Date/ Site Implementation Date and Next review date.

In case of copy of master index is required for reference the same shall be taken only by QA, signed and stamped with UNCONTROLLED stamp and issued.

Whenever a photocopy of the Master document is required to be given to any department of site, then it shall be stamped as ‘CONTROLLED COPY’ at the top right side of the document on all pages. First page of the SOP/GTP is to be stamped with control copy stamp having dept. code and issued by sign& date whereas rest of the pages to be stamped with only controlled copy stamp.

Whenever a photocopy is to be given as a reference (e.g. regulatory authorities/other sites/contract laboratories) the same shall be stamped as ‘UNCONTROLLED COPY’ on top of the document on all pages.

QA shall distribute photocopies of master copy ‘CONTROLLED COPY’ to the concerned departments for usage and simultaneously withdraw the superseded versions.

The issuance, withdrawal and destruction of controlled copies of the SOPs shall be recorded by QA in the format.

The master copy of the withdrawn SOP/GTP shall be stamped as ‘OBSOLETE’ on the first page at the top right hand corner above the header of the document and archived at QA.

All SOP/GTP shall be reviewed every 3 years, and the applicable /necessary revision/s shall be made following a change control procedure as per respective SOP. If no revision is necessary, then the SOP/GTP shall be reprinted and approved with new revision number. In the revision history “SOP/GTP Reviewed and no change” shall be written.

The MASTER copy shall be in red color ink, CONTROLLED copy in green color ink, UNCONTROLLED copy in blue color ink and OBSOLETE copy stamp in black color ink for better differentiation.

Note: Respective site can follow their site SOP for handling and control of stamps.

Whenever an SOP/GTP is discontinued master index shall be updated by putting withdrawn/ obsoleted in the next review date column against the SOP/GTP. The document number of the discontinued document shall not be assigned to any other document.

For the storage, retrieval and destruction of the SOP/GTP, respective procedure shall be followed.

ABBREVIATIONS:

GTP: General test procedure

E.g. For example

Etc. Etcetera

PDF: Portable Document Format

PREPARATION AND REVIEW PROCEDURE OF ANNUAL PRODUCT QUALITY REVIEW (APQR)/ PRODUCT QUALITY REVIEW (PQR)