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Document and Data Control in Pharmaceuticals SOP

In SOPs of Document and Data Control, we come to know how Pharmaceuticals industries are putting SOPs and Form number, which are used in a different parts of industries.

Document and Data Control Importance

Document and Data Control have significant importance in Pharmaceuticals because every document in the pharmaceuticals industry need a number which refer to the documents, that’s why in every form, SOPs, log book or any other documents you will see the Document and Data Control listed number.

Document and Data Control

PURPOSE

To ensure that all documents are controlled and distributed so that only current issues are in use by those Employees requiring them. Documents are properly reviewed and approved prior to issue and changes to documents are properly authorized. To ensure that all documents will go through a periodic revision check for continuous suitability.

SCOPE

This SOP of Document and Data Control covers all document control activities in Pharmaceuticals industry.

RESPONSIBILITY

3.1 The Quality Assurance Manager has the responsibility for directing activities relating to this SOP of Document and Data Control.

On the other hand remaining have responsibility, they are so represented.

3.2 Concerned Department Heads are responsible for maintaining the master list of documents used in their departments for Document and Data Control.

MATERIAL & EQUIPMENT

4.1 Rubber stamps

PROCEDURE

The following documents are under the document & data control system of Document and Data Control.

DOCUMENT HIERARCHY

Level 1: Manual, Policy.
Level 2: All types of procedures e.g. Standard Operating Procedures, Job Descriptions, Sanitation SOPs, Calibration Procedures, and Instrument Operating Procedures etc.
Level 3: All records e.g. General Records: Quality Records, Batch Manufacturing Record (BMR), and Logs Books

DOCUMENT CODING

5.2.1 The upper corner of pages contains where practicable:
Document Code / SOP # example PR/2/01
QA/2/01
Revision/Issue # example Revision #1
Page Number
example Page 1/4 or Page 1 of 4
Effective Date and Review Date
5.2.2 The document code is of the form AAA/B/CCC, where.
AAA is the department (see list below). Can be 2 to 6 letters.
B is the document level, 1-3
CCC is the individual document number for Level 2-3, starting from 1 or 01 or 001 serial numbers of documents may not be in sequence. Some number may be missing in the series.

5.2.3   Abbreviations:

Abbreviation Department/Function
HR Human Resource Management
MR Management Representative
JD Job Description
TD Training & Development
MK Marketing and Sales
MN Maintenance Department
PRD Production
PRDS General SOPs for Oral Liquid section
PRDCLS Cleaning SOPs for Oral Liquid section
PROOS Operational SOPs for Oral Liquid  section
PRDI General SOPs for Injectable section
PRDCLI Cleaning SOPs for Injectable section
PRDOI Operational SOPs for  Injectable section
PU Purchase
C Instrument Calibration with section code
QC Quality Control
QCM Quality Control (Micro)
QCRA QC RM Analytical Procedure
QCRS QC RM Specification
QCPM QC PM Specification
QCIA QC Inprocess Analytical Procedure
QCIS QC Inprocess Specification
WR Ware house
QCFA QC FG Analytical Procedure (Human)
QCFS QC FG Specification
PRDCLP Cleaning SOPs for Powder section
PRDOP Operational SOPs for Powder section
PRDD General SOPs for Drench section
PRDCLD Cleaning SOPs for Drench section
PRDOD Operational SOPs for Drench section
PRDI General SOPs for Injectable section

5.2.4   These codes are further advanced to identify sub-divisions of departments for example:

PRH stands for, Production-Human PRV stands for, Production-Vet,. All departments are carefully coordinated to avoid over-lapping of codes and the usage of the same letter for two different types of documents.

For example : Production-Human and Production-Vet both begin with the letter “P”, therefore “H” is used for Production-Human and “V” is used for Production-Vet. Also Water Mark “VET” is present on Production-Vet SOPs, BMR and QC Specification, and QC test reports.

5.2.5  Further division of documents in Production and Quality Control is carried out carefully and code list is prepared by each department and copy is provided to QA.

DOCUMENT STRUCTURE

The standard Format of SOP has been circulated to all departments.

5.3.1 SOP’s may contain the following headings:

Title & code #

Prepared by,

Reviewed by

Approved by

Authorized by

Revision #

Reporting

Effective Date

Purpose

Scope

Responsibility

Materials & Equipment

Procedure

Precaution (where required)

Reporting

Reference Documents

5.3.2 Standard Analytical Procedures and Specifications may have different standard format.

DOCUMENT REVIEW/ APPROVAL

5.4.1 Documents are written by the appropriate personnel in consultation with the Head of the Department involved with the activity.

5.4.2 Documents review system may be changed incase of Policies, JDs etc but with agreed system of Document and Data Control.

 

          Review & Revision

Department Prepared By Reviewed By Approved By Authorized By
QA QA Officer QAM QCM Executive Director
QC QC Officer QCM QAM Executive Director
Production Production Officer PM QAM Executive Director
Warehouse Warehouse Incharge PM QAM Executive Director
Purchase Purchase Officer Purchase Manager QAM Executive Director
Maintenance MNT Incharge PM QAM Executive Director
HR HRO HRM QAM Executive Director

ISSUING DOCUMENTS

5.5.1 Level 1 and 2 documents are stamped with the Official Red Stamp “CONTROLLED” (except for original).
5.5.2 Uncontrolled Photocopies of level 1-3 are only allowed for use outside the working system, e.g. by customers, auditors, consultant. These are Red stamped as “For Reference Use” at least on the first page of the document.
5.5.3 The original document, signed and dated, (un-stamped) is retained by Respective department with sample formats attached.
5.5.4 The Batch Manufacturing Record (BMR) will be issued for every batch according to production schedule by the QA Manage, stamped with the Official Red Stamp “CONTROLLED” and are entered in the specific QA Batch Cards Issuance Logs.
5.5.5 A Circulation Form accompanies the original documents which indicate the distribution list for a particular document. (Circulation form can be replaced if it is damaged.) This does not apply to the issue of BMR.
5.5.6 Copies of documents are distributed to the appropriate personnel who sign the Circulation Form. The preparation and updating of the SOP is the responsibility of the departmental heads who signs the circulation form for the compliance of SOP in circulation.
5.5.7 The Quality control documents which have only one copy with Q.C. do not require that the circulation form is filled.
5.5.8 The QA Manager is authorized to change batch size or update format in Batch Manufacturing Record (BMR) in case of any shortage or problem. The Revision/Issue No. of Batch Manufacturing Record (BMR) changes when there is a change in the formulation of the product only.
5.5.9 New Batch Manufacturing Record (BMR) issued for production is stamped with the Official Red Stamp “CONTROLLED”.

AMENDING DOCUMENTS

5.6.1 Changes required are raised in a Document Change Request Form and submitted to the QA Manager.
5.6.2 Authorization of proposed change is given by QA Manager for Technical Documents in consultation with the functions that initially wrote and approved and authorized the document. For QA Manager documents including the Quality Manual, the authorization is given by the Executive Director.
5.6.3 When the document is changed, the issue/revision number advances, e.g. Revision/Issue 00 to Revision / Issue 01 & changes are mentioned on the Document Change Request form.
5.6.4 For changes on BMR, a Product Change Request form should be raised and submitted to the QA Manager.

WITHDRAWAL OF OBSOLETE DOCUMENTS

5.7.1 The related column which indicates “date of return” of the previous revision/issue on Circulation Record Form is filled by the concerned person and the obsolete copy is withdrawn and destroyed.
5.7.2 For the circulation of the new revision/issue, the next column of the CIRCULATION FORM which indicates the next issue number is signed by the concerned person upon receiving the new issue in the “received by” column.
5.7.3 The original copy of the obsolete document, along with the Document Change Request Form, is kept in an Obsolete Document File. The front page of the document is red stamped “Obsolete”.
5.7.4 If the obsolete document are required for reference use they will be stamped “For Reference Use “and will be segregated from documents in use. Other Company records can also be kept similarly.

ISSUING & AMENDING LEVEL 3 FORMATS

5.8.1 Generation of formats is the responsibility of department heads.
5.8.2 They include a code number on all formats and issue number where practicable.
5.8.3 A sample copy is attached to the relevant SOP for reference. If the same format is used for more than one SOP, then it need not be attached with every SOP.
5.8.4 The formats are changed as per section 5.6 and the latest copy is replaced as per point 5.7. The expected starting date (effective date) of the format is mentioned in the Document Change Request form.
5.8.5 The obsolete version of the format is retained in the obsolete documents file.
5.8.7 Copies are allowed for working activities.
5.8.8 List of Control of Records and retention location, time is maintained by respective department Head.
5.8.9 All Manufacturing, Packaging & Q.A/Q.C Record related to batch processing, testing & release will be retained for a period of one year after the expiry of the batch.
5.8.10 Department head ensures that all documents are kept in appropriate container (preferably a file), the file is clearly labeled and make sure that there is no deterioration during period of retention.
5.8.11 All document container / file are to be examined by the Keeper of the document and the expired documents are taken out of the container for disposition.
5.8.12 The Departmental Heads ensure that the expired documents are retained to become a part of the company history if required after the retention period otherwise it is destroyed.
5.8.13 On the expiry of retention period, if record is still required to be retained, identify it as “For Reference Use” in red by a concerned person and file them separately such that the obsolete records are clearly distinguished from the un-expired records.
5.8.14 The Backup data of user files and data base files saved on Managers Computers and stand alone computers attached with QC instruments (e.g. HPLC, UV/Visible Spectrophotometer etc.) is taken by IT department on monthly basis.
5.8.15 In case of any mistake during recording information, correction may be made in a way that original entry is still legible. For that the incorrect information should be crossed by single line like “65.9Kg”and correction should be made adjacent to it. The person making the correction must sign with date after correction is made. Over-writing, Blanco, or any other means to erase or mask the original entry is not allowed.

DOCUMENT CONTROL MASTER LIST

5.9.1 Departmental heads will maintain & update Master List of Controlled Documents (All levels) in form according to SOPs of Document and Data Control.

CONTROL OF EXTERNAL ORIGIN DOCUMENTS

5.10.1 External origin documents like the ISO standards will be controlled similarly to the internal documents. It will be circulated on the circulation form & in case of amendment in the Standard the new copies will be issued and Obsolete copies will be withdrawn. Other External origin documents e.g. Drug Act, cGMP guidelines and other reference books are available in QC for Consultation. Copies of cGMP guidelines are circulated for the purpose of training and better understanding. These documents are not controlled like internal documents. Latest editions are purchased as & when required.

6. REPORTING

6.1 Circulation Record
6.2 Document Change Request Form
6.3 Master List of Controlled Documents
6.4 List of Control of Record

7. REFERENCE DOCUMENTS

7.1 SOP for Archiving of QC Electronic Data.
7.2 Product Change Request Form
7.3 Archiving of QA Electronic Data

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