SOP for Document Control

PURPOSE

To lay down the procedure for executing control on the activities involved in the preparation, distribution, issuance, retrieval, destruction, and archival of documents.

SCOPE

This procedure shall be applicable for Quality-related documents issued by Quality Assurance at PharmaInfo Limited.

RESPONSIBILITY

User Department personnel

• To prepare the Documents, as applicable
• To request for the Issuance of Logbooks and log cards and to retrieve the same to QA after execution.

Quality Assurance Personnel

• To prepare the master and control copies of the Documents.
• To issue, distribute, retrieve, archive, and destroy the controlled and uncontrolled copies of documents.
• To maintain and control the documentation system.

Head – Quality Assurance

• To ensure the overall compliance of the laid down procedures.

DEFINITIONS

Standard Operating Procedure (SOP): A written, and controlled document used to delineate a process, procedure, or practice which is required to be consistently performed.

Master Document: A paper original containing ink signatures or an effective electronic document containing electronic signatures.

Controlled Document: This document is maintained updated and has version control. These documents are formally approved, and their distribution is traceable to enable changes that shall be executed

Version: All the controlled documents have version numbers which get changed whenever there is a change in the SOP. Version No of SOP shall start from 01 serial.

Questionnaire: A questionnaire is a tool/medium consisting of a series of questions and other prompts for the purpose of assessing the effectiveness of training by recording the information from the trainee.

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PROCEDURE

• All the documents used at the site shall be controlled by the Quality Assurance department.
• Every documentation used at the site shall have a unique identification number and format number and it must be indicated in each format.
• All the formats (which shall be further issued for data recording) such as Usage Logbooks, Calibration formats, and any other data recording sheets shall be prepared by the concerned department and shall be approved, distributed/issued, and retrieved as per the respective SOPs. These formats shall be part of the respective SOPs (as Annexures).
• Documents like Specifications, Standard Test Procedures, Stability Protocols, and Hold time protocols shall be prepared as per their respective formats and approved, distributed/issued, and retrieved by the Quality Assurance at the site.
• Documents like Manufacturing and Packaging Records, Batch Sampling Plans, and Validation Protocols shall be prepared by the Quality Assurance. They approved, distributed/issued, and retrieved by the Quality Assurance at the site.
• Distribution of Standard Operating Procedures and specifications, Standard Test Procedures, and Others:

• This procedure shall be followed for the Issuance of controlled copies of the SOPs, STPs, specifications, and any other documents, for which the controlled copy issuance is necessitated.
• Upon receipt of the approved copies of the Document, QA personnel shall ensure signature on all the pages of the document and shall make the document effective after ensuring completion of the training by stamping the date in the format DDMMYY, where DD-Day, MM-Month, and YY- Year.
• The next Review date shall be 36 months from the effective date and the same shall be stamped in the format DD/MM/YY.
• QA shall put the stamp as ‘Master Copy’ on the bottom right corner of every page in Blue ink.

• The QA personnel shall take the required number of copies of the documents from the master copy as per the distribution requirement.
• QA shall put the controlled copy stamp on the bottom left corner on all the pages of the document in Blue ink as given below,

• Controlled copies such as instrument/equipment log sheets, room cleaning logsheets, and the issuance details such as Issued by and Copy No. shall be recorded in “Distribution, Retrieval and Destruction Record of Controlled Documents”.
• If any Document is required by the regulatory authority and/or contractors, copies shall be made from master copy, and the “Uncontrolled Copy” stamp shall be affixed at the Top left in Red ink on all the pages, as given below,

• While issuing the uncontrolled copies, the issuance details such as Issued by, Sent to, and Date of Issue. shall be recorded in the “Distribution Record of Uncontrolled Documents”.
• If in case the uncontrolled copy is required to be shared electronically, the uncontrolled copy prepared as per the above procedure shall be scanned and shared with the concerned personnel. After sharing the scanned copy of the uncontrolled copy the hard copy of the uncontrolled copy shall be destroyed immediately.
• No photocopies of controlled copies of documents are permitted (except annexures). Only the photocopying of the Master copies by the authorized QA personnel is allowed for the preparation of Controlled and uncontrolled copies.
• Master Copies of all documents prepared at the site shall be under the control of the Quality Assurance department. Access to both hard and soft copies of the Master documents shall be minimized to the possible extent.

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Retrieval of Obsoleted Documents

• If the document is revised for any reason, then the controlled copies of the document that has been issued shall be immediately changed with a new controlled copy. The old controlled copies shall be retrieved and destroyed.
• QA shall be responsible for ensuring the current and most recent version of the controlled copy is made available. Each time a document is updated/revised, the controlled copy(s) on the shop floor/Departments shall be replaced and the issuance record shall be corrected.
• After the revision of any document, On the effective date of the new version, the document with the earlier version shall be retrieved by the Department Head and replaced with the new version.
• The distributed controlled copies of documents, as per the distribution list shall be collected by QA. All retrieved (controlled) copies of documents shall be destroyed by Quality Assurance.
• The retrieval and destruction of the documents shall be recorded in the ‘Distribution, Retrieval, and Destruction record of Controlled Documents’.
• Master copies of the obsoleted Documents will be stamped as “Obsolete Copy” in ink at the bottom center of the page after implementation of the revised SOP, as given below. The person obsoleting the copy shall record his signature with the date beside the ‘Obsolete Copy’ stamp, on the first page of the document.

• The obsoleted copies of the SOPs shall be stored in the Documentation cell, in the custody of Quality assurance personnel.

Formats

The formats of the SOP shall be used in four different types as explained below,

• Formats for distribution shall be photocopied from the controlled copy SOP formats.
• The user shall make photocopies from the controlled copy of the annexure issued to the respective department as a part of the SOP attachment and take photocopies to QA to stamp as issued for raw data traceability.
• Annexures to be distributed shall have the below ‘ISSUED BY QA’ (Department of issue inscribed on stamp) stamped at the bottom of the page in the middle and Quality Assurance personnel shall sign the photocopy and the same can be used for execution.

• The QA signature shall be taken prior to the usage of the Annexure and any of these shall be not used without the QA Issued by signature.
• The issuance of the calibration formats (SOP formats) shall be handled as per below:

Preprinted Stationary (e.g. Log Book / Register) and Calibration formats.

1. The valid format of SOP shall be used for printing the Log Book / Register.
2. The printed Log Book / Register shall be verified for the contents with the respective format from SOP at the time of first print proof and at the time of each receipt.
3. The format number of the printed Log Book / Register shall be verified at the time of issuance for its validity.
4. The calibration formats shall be issued by photocopying the issued controlled copies of the SOP.
5. The user department shall request the Quality Assurance for the required ‘Format / Log Card / Log Book’ as per SOP (Logbooks, Log Cards & Formats Issuance and Retrieval Record).
6. Issuance of preprinted stationary (e.g. log card) shall be done by the Quality Assurance personnel and the details of issuance shall be recorded in the Logbooks, Log Cards & Formats Issuance and Retrieval Record.
7. Every issued logbook, log card and format shall have an issuance number ‘XXYYMM ZZZ’ as elaborated below,

XX – stands for the Department name as indicated below, QA – Quality Assurance, QC – Quality Control, PD – Production, WH – Warehouse, EN – Engineering, AD – Administration.

MM- stands for the month.

YY- stands for the last two digits of the issued year.

ZZZ – stands for the serial number, starting from 001 for each department in the year.

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For example, the second logbook issued for Production in the year 2023 shall be numbered as ‘PD2306002’. The SOP issue number will be given as XXYYZZZ e.g. first SOP from QA to Production will be PD23001 Where XX, YY, and ZZZ are as stated above.

Retrieval of Logbooks, Logcards, and Formats

• The executed/completed Log Card, Log Book, and Calibration format shall be retrieved back to QA upon completion of the log card or month or year as applicable to the Quality Assurance department.
• Based on the applicability of the format, the logbooks or registers shall be retrieved back to QA at the end of the year or the same can be continued for the following years.
• If the logbook is required to be continued for the following year, the details of same shall be recorded in the Annexure: (Logbooks, Log Cards & Formats Issuance and Retrieval Record) of both the current year and the following year.
• All retrieved Log Card, Log Book, and Calibration format copies shall be archived in the Quality Assurance Department.
• All copies of the Log Card, Log Book, and Calibration format shall be reviewed by the respective department before final submission to QA.

Soft Copy/Templates (e.g. Format specified in SOP for preparation of any of list)

• The user department shall prepare the required soft copy in Word/excel format by taking reference to the corresponding valid format available in the SOP.
• This soft copy after verification shall be used further (e.g. Preparation of list).
• The person using the soft copy shall be responsible for verification of the content of the format with the respective SOP.
• Every document prepared/ updated by using a soft copy shall be printed and signed. Any unsigned copy shall not be treated as a valid document.
• Loose Formats are required to be issued along with the Batch Production Record. Shall be issued as per annexure shall be followed.

Receipt & Storage of Documents

• All the documents and records (such as analytical raw data, executed BMRs & etc., excluding the documents issued as per Annexure-3) after they are approved/completed, shall be handed over by the respective departments to QA.
• The submitting department shall ensure that the documents/records are either filed or submitted as bound books.
• Each file or bound book shall be labeled by the submitting department for proper identification.
• The numbering of the submitting document shall be done as ‘SM/XX/YY/ZZZ’ as elaborated below,

SM – stands for the ‘submission of the GMP document’.

XX – stands for Department name.

YY- stands for the last two digits of the issued year.

ZZZ – stands for the serial number, starting from 001 for each department in the year.

For example, the second document submitted by Quality Control in the year 2023 shall be numbered as ‘SM/QC/23/002’.

• QA shall receive the files/log books, verify that the document/record is approved (final approval as per the respective SOPs) and that appropriate information is available on the label (At a minimum, document name, document number, and file submission number shall be available on the label).
• Entry shall be made by the respective department and QA personnel for all submitted documents in the ‘Document Submission Logbook’ register as per Annexure-4.

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• The ‘Document submission logbook’ shall be available with QA.
• QA shall arrange all the files / log books in the designated place and retain them till the end of the storage period as defined in ‘Storage Periods of GMP Documents’ (Annexure-5).
• If a document is required by any person for reference purposes, a ‘Document Issuance Request’ as per Annexure-6 shall be filled and submitted to QA. The form shall state the exact reason for the withdrawal of any document. The request shall be archived as per the retention period defined in Annexure-5.
• The Document Issuance Request form shall have the document Name or Product Name, Document No. or Batch No. with the reason for withdrawal. The request shall be duly signed by the requested person, the head of the initiating department, and finally approved by the QA Head/designee.
• QA personnel shall ensure that the issued document is returned and the Document Issuance request is duly filled.
• QA personnel shall review the list of available documents in the documents storage room and identify the records, which had crossed the retention period for destruction. The identified records shall be destroyed after the QA Manager’s approval as per the ‘Document QA personnel shall ensure that the issued document is returned and the Document Issuance request is duly filled.
• Note: For BMRs, BPRs, and Protocols/ Reports record on a controlled copy then issue by stamping both stamps in blue ink.

ANNEXURES

Annexure No.-1: Distribution, retrieval, and destruction of records of Controlled documents.

Annexure No.-2: Distribution record of Uncontrolled documents

Annexure No.-3: Logbooks, log cards & formats issuance and retrieval record

Annexure No.-4: Document Submission Logbook

Annexure No.-5: Storage Periods of GMP Documents

Annexure No.-6: Document Issuance Request

Annexure No.-7: Document Destruction Record

ABBREVIATIONS

QA: Quality Assurance

QC: Quality Control

SOP: Standard Operating Procedure

REVISION HISTORY

Nil

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