Document and Data Control in Pharmaceuticals Plant

Standard Operating Procedure of Document and Data Control in Pharmaceuticals Plant is describe in this post.

{getToc} $title={Table of Contents}

1. PURPOSE

To ensure that all documents are controlled and distributed so that only current versions are in use. All documents are prepared, reviewed and approved prior to authorization and also changes to documents are controlled. To ensure that all documents will go through a periodic review for document suitability check.

2. SCOPE

This SOP covers all document control activities in Pharmaceuticals.

3. RESPONSIBILITY

3.1 The Quality Assurance Manager has the responsibility for directing activities relating to this SOP. 

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

4. MATERIAL & EQUIPMENT

    Rubber Stamps

5. PROCEDURE

The following documents are under the document & data control system:

• Manual
• Policy
• Standard Operating Procedure (SOP)
• Record Form
• Batch Manufacturing Record (BMR)

5.1 DOCUMENT HIERARCHY 

       Table -1

Document Level	Type of Document
Level 1	Manual and Policy
Level 2	All types of procedures e.g. Standard Operating Procedures, Job Descriptions, Calibration Procedures, Instrument Operating Procedures etc.
Level 3	All records e.g. Production IP Records, QA IP Records, Quality Control Records, Batch Manufacturing Record (BMR) and Log Books etc

5.2 DOCUMENT CODING

5.2.1 The upper corner of pages contain where practicable: 

Table-2

Document Code #	Example:	QA/2/001
Revision #	Example:	Revision # 01
Page Number	Example:	Page 1of 4
Effective Date and Next Review Date	Example:	01-01-2020 - 01-01-2023 (DD-MM-YYYY)

5.2.2 The document code is of the form AAA/B/CCC; where:

AAA is the department (see list below). It can be 2 to 8 letters.

B is the document level, 1-3

CCC is the individual document number for Level 1-3, starting from 001 serial number.

5.2.3 Abbreviations: Table-3

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
PRH	Production Human
PRHT	General SOPs for Oral solid section
PRHCLT	Cleaning SOPs for Tablet section
PRHOT	Operational SOPs for Tablet section
PRHCLC	Cleaning SOPs for Capsule section
PRHOC	Operational SOPs for Capsule section
PRHS	General SOPs for Oral Liquid section
PRHCLS	Cleaning SOPs for Oral Liquid section
PRHOS	Operational SOPs for Oral Liquid  section
PRHI	General SOPs for Injectable section
PRHCLI	Cleaning SOPs for Injectable section
PRHOI	Operational SOPs for  Injectable section
PU	Purchase
C	Instrument Calibration with section code
WR	Ware house
QC	Quality Control
QCM	Quality Control (Micro)
QCRA	QC RM Analytical Procedure (Human)
QCRS	QC RM Specification (Human)
QCPS	QC PM Specification (Human)
QCIA	QC Inprocess Analytical Procedure (Human)
QCIS	QC Inprocess Specification (Human)
QCFA	QC FG Analytical Procedure (Human)
QCFS	QC FG Specification (Human)
PRHSS	General SOPs for Semi Solid section
PRHCLSS	Cleaning SOPs for Semi Solid section
PRHOSS	Operational SOPs for Semi Solid section
PRHCC	General SOPs for Dry Powder Capsule section
PRHCLC	Cleaning SOPs for Dry Powder Capsule section
PRHOCC	Operational SOPs for Dry Powder Capsule section
LMS	Lab Management System
PRV	Production Vet
PRVB	General SOPs for Bolus section
PRVCLB	Cleaning SOPs for Bolus section
PRVOB	Operational SOPs for Bolus section
PRVCLP	Cleaning SOPs for Powder section
PRVOP	Operational SOPs for Powder section
PRVD	General SOPs for Drench section
PRVCLD	Cleaning SOPs for Drench section
PRVOD	Operational SOPs for Drench section
PRVI	General SOPs for Injectable section
PRVCLI	Cleaning SOPs for Injectable section
PRVOI	Operational SOPs for  Injectable section
PRVA	General SOPs for Aerosol section
PRVCLA	Cleaning SOPs for Aerosol section
PRVCLA	Cleaning SOPs for Aerosol section
PRVOA	Operational SOPs Aerosol section
PRHB	Production Human BMR
PRVB	Production Vet BMR
QCI	Instrument Operational Procedures
QA	Quality Assurance
CL	Machine cleaning Sops with section code
ADM	Administration
QM	Quality Manual
QP	Quality Policy
QCRAV	QC RM Analytical Procedure (Vet)
QCRSV	QC RM Specification (Vet)
QCPSV	QC PM Specification (Vet)
QCIAV	QC Inprocess Analytical Procedure (Vet)
QCISV	QC Inprocess Specification (Vet)
QCFAV	QC FG Analytical Procedure (Vet)
QCFSV	QC FG Specification (Vet)
PRHCI	General SOPs for Dry Powder Injection section
PRHCLCI	Cleaning SOPs for Dry Powder Injection section
PRHOCI	Operational SOPs for Dry Powder Injection section
PRHCS	General SOPs for Dry Powder Suspension section
PRHCLCS	Cleaning SOPs for Dry Powder Suspension section
PRHOCS	Operational SOPs for Dry Powder Injection section
LMSP	Lab Management System Policy

5.2.4 These codes are further advanced to identify sub-divisions of departments for example: PRH stands for Production Human and PRV stands for Production Vet (Veterinary). All departments are carefully coordinated to avoid over lapping of codes and the usage of the same code 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 Quality Assurance.

5.3 DOCUMENT STRUCTURE

Document structure contains these item; Document Header, Hierarchy, Document Detail. For better understanding document structure for each level of document is discussed in detail.  

5.3.1 Document Structure for Level-1 Documents: 

A.  Document Header for Level-1 Documents: 

Document header is same for all documents of level-1 i.e. Manual and Policy.

Manual and policy contains the following header

logo	TITLE:	DOCUMENT TITLE
	Department	Name of Department
Doc. #	Revision #:		Effective Date	Next Review Date

The header contains: 

• Company Logo
• Document Title
• Department Name
• Doc. #, Revision #, Effective Date, and Next Review Date. 

B. Hierarchy: 

The hierarchy for these documents is Prepared By, Approved By and Authorized By.

C. Document Detail:

• For Manual is according to its standards format of the specific management system in compliance of high level structure of documents. 
• For policy the document detail is composed of purpose, scope, and necessary detail of the subject matter under discussion.

5.3.2 Document Structure for Level-2 Documents: 

A. Document Header for Level-2 Documents: 

• Document header is same for all documents of level-2 i.e. Standard Operating Procedures (SOPs), Job Descriptions (JDs), and Instrument Operating Procedures 

Level-2 Documents have the following header

logo	DOCUMENT TITLE			Doc #:
				Revision #
				Effective Date
				Next Review Date
TITLE
	Prepared By	Reviewed By	Approved By		Authorized By
Name
Designation
Signature
Date

The header contains:   

• Company Logo
• Document Title i.e. Standard Operating Procedure
• Doc. # 
• Revision # 
• Effective Date
• Next Review Date
• Title (for procedure) 
• Name (of person: Involved in document preparation, Review, Approval and Authorization  
• Designation (of person): Involved in document preparation, Review, Approval and Authorization 
• Signature (s)
• Date (of signature)  

B. Hierarchy: 

The hierarchy for level 2 documents is as follows: 

• For Job Descriptions (JDs) is according to Procedure for Human Resource Management. 
• For Standard Operating Procedure (SOPs)

Table - 4

Department	Prepared By	Reviewed By	Approved By	Authorized By
Quality Assurance	Quality Assurance Officer	Senior QA Officer	Quality Assurance Manager	Director Technical
Quality Control	QC Officer / Microbiologist	Quality Control Manager	Quality Assurance Manager	Director Technical
Production	Production Officer	Production Manager	Quality Assurance Manager	Director Technical
Warehouse	Warehouse Incharge	Production Manager	Quality Assurance Manager	Director Technical
Purchase	Purchase Officer	Purchase Manager	Quality Assurance Manager	Director Technical
Maintenance	Maintenance Incharge	Production Manager	Quality Assurance Manager	Director Technical
HR& Admin	Human Resource Manager	Admin Manager	Quality Assurance Manager	Director Technical

C. Document Detail 

Document detail for Standard Operating Procedure (SOPs) is according to this  standards format as follows: Purpose, Scope, Responsibility, Materials & Equipment, Procedure, and Precaution (where required), Reporting / Required Documents, Reference Documents and Change History.

For Job Descriptions (JDs) the document detail is as follows:

Job Summary, Duties and responsibilities, skills and job specification.

5.3.3 Document Structure for Level-3 Documents: 

A. Document Header for Level-3 Documents: 

Document header is same for all documents of level-3 i.e. Record Forms and Batch Manufacturing Record (BMR).

Following header is used for Record Forms in Level-3 documents:

	TITLE:	DOCUMENT TITLE
	Department	Name of Department
Doc. #	Revision #:		Effective Date	Next Review Date

The header contains:     

Company Logo

Document Title

Department

Doc. #, Revision #, Effective Date, and Next Review Date.

 

Following header is used for Batch Manufacturing Record (BMR) in Level-3 documents:

	DOCUMENT TITLE	Doc. No.	Version: ##
	Product Name
		w.e.f.	Page #
	Batch No.   AA###	Registration  No.	######

B. Hierarchy: 

The hierarchy for level 2 documents is as follows: 

Record forms are used and signed as per routine activities.

The hierarchy for Batch Manufacturing Record (BMR) document is as follows:

Formula Prepared By:	Formula Checked By:
Production Officer	Production Manager	QA Manager
Sign: _________ Date: ________	Sign: ______ Date: ______	Sign: _________ Date: _________

C. Document Detail 

For Record Form document body is according to the requirement procedure for which format is developed. So, different formats can be comprised of different details.

For Batch Manufacturing Record (BMR) document the document body detail is as follows:

• Manufacturing Order

• Equipment Detail

• Procedure (with process, specifications and sampling details where required)

• Packing order

• Primary and secondary packaging process

• Over-printing procedure

• FG Sampling and FG Transfer details

• Reconciliation

• Document review by Production and Quality Assurance 

5.4 DOCUMENT AUTHORIZATION

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 The author sends a soft copy of the SOP to the department head for review of the contents.

5.4.3 After review, the department head forwards the SOP to QA.

5.4.4 QA reviews the content with reference to format and technical aspects. 

5.4.5 QA keeps the finalized soft copy after approval of the document.

5.4.6 QA will approve the new document for further procedure, i.e. printing and signing of the document with concerned autho

5.4.7 rities.

5.4.8 Document author will print out the final document on A4 size white paper and circulate to the approvers for approval signatures.

5.4.9 The approval date will be the date of the final approval signature.

5.4.10 Director Technical will authorize the document and from next working day the document will be effective.

5.4.11 The effective date may be up to 10 working days from the date of authorization to provide a window for training and compliance to the document. Where urgently required a document may be issued as approved, authorized and immediately effective, but making sure that at the time of the effective date the SOP should be read and understood by impacted site and functional group heads as relevant to the Document.

5.4.12 Appropriate Standard Operating Procedures should be in place as relevant to the work station.

5.4.13 QA and Author have the access to “Master Document File”.

5.4.14 The signed hard copy version will be stamped as “MASTER” in Green colour on right upper corner of the each page.

5.4.15 Get the photo copies of the document stamped as “Master” copy with Green colour stamp.

5.4.16 Place this “MASTER” document in a separate folder and affix appropriate label.

5.5 DOCUMENT ADMINISTRATION

5.5.1 A log book will be maintained for hard copies at QA department for all type of documents.

5.5.2 Departmental heads will also maintain & update “Master List of Controlled Documents” (All levels) in relevant form.

5.5.3 All identified documents will be circulated to the respective departments on the document circulation form.

5.5.4 Respective department is responsible to circulate defined type of document copy to the concerned departments. 

5.5.5 QA Department is responsible to assure the circulation of defined copies to the concerned departments.

5.5.6 The working copy will be circulated to the departments who are directly involved in the processes.    

5.5.7 Stamp the photocopy of “MASTER” stamped document with “WORKING” stamp in blue ink.

5.5.8 The following information will be included in the log book: issuance date, document number, version, and distribution list, signature of receiving person with date.

5.5.9 Department head will provide the photocopies required for circulation.

5.5.10 Photocopying of all documents from Level 1-3 shall be strictly prohibited without appropriate approval.

5.5.11 Photocopying and printing as note pads of documents from Level 3 shall be permitted after complete verification of the ready to print draft. The draft sent to printer will be verified and approved by concerned department head and QA head.

5.5.12 If needed any additional copy of SOP, the concerned personnel shall make request to Quality Assurance Department for provision of document working copy.

5.5.13 Any SOP issued for non-operational use (to the customers and regulatory agencies) shall be copied from “MASTER” and stamped as “REFERENCE” in blue colour on the text matter of every page.

5.6 AMENDING DOCUMENTS

5.6.1 For planned changes required revisions are raised in a “Document Change Request Form” and submitted to the QA department. 

5.6.2 In case of any unplanned necessary changes deviation will be recorded with reference to relevant clause and signed by the author and approvers and will be communicated to all concerned departments. This change will be documented in print within 15 days of this activity 

5.6.3 Approval of proposed change is given by QA Manager for all technical documents in consultation with the author and other key personnel.

5.6.4 For QA Department technical documents the approval is given by the Director Technical.

5.6.5 When the document is changed, the revision number advances, e.g. Revision 00 to Revision 01 & changes are mentioned on the “Document Change Request Form”. However, if there is only periodic revision then no need to raise “Document Change Request Form”.

5.6.6 For planned changes on BMR, a Product Change Request Form” shall be raised and submitted to the QA department.

5.7 REVISION AND RETRIEVAL OF DOCUMENTS 

5.7.1 For planned changes on BMR, a Product Change Request Form” shall be raised and submitted to the QA department.

5.7.2 The review period for SOPs is 3 years, although when required to meet regulatory or business changes, SOPs will be updated within that period.

5.7.3 At the time of periodic review if there is no change required in the SOP, the back side of first page of “MASTER” copy is written with green ink pen having the following information;

“Reviewed, No changes are required”

Reviewed by: ___________________

Next Review Date: _______________

5.7.4 In case of no change required extend the next review date for three year.

5.7.5 Whenever the SOP is revised, the same procedure for approval of SOP is repeated and version number is changed to the next.

5.7.6 At the time of issuance of new version, withdraw all the issued copies of the old version simultaneously and update the log book accordingly.

5.7.7 In case of cancellation or revision of any SOP, withdraw the controlled copies from the individual departments, retrieve and destroy. “MASTER” shall be stamped with “OBSOLETE” stamp in red colour at the top right hand side of the SOP. 

5.7.8 Keep the obsolete documents in a separate folder labelled as “Obsolete Document File” in QA department.

5.7.9 Such copies shall be archived by QA department along with the respective change control. In such case follow the document change control initiation as per SOP (Title: Document Change Control).

5.7.10 Keep one copy of last obsolete version for record.

5.8 ISSUING DOCUMENTS

5.8.1 Circulation of Working Copies of Level 1 and 2 documents are stamped with the “WORKING” Stamp.

5.8.2 Photocopies of level 1-2 are only allowed for use with “REFERENCE” stamp outside the working system, e.g. by customers, auditors, consultant.

5.8.3 The original document, signed, dated, and stamped as “MASTER” is retained by respective department with sample formats attached.

5.8.4 The Batch Manufacturing Record (BMR) will be issued for every batch according to production schedule by the QA department, stamped with the Official Red Stamp “CONTROLLED” on each page and also specific BMR Issuance Logbook will be maintained.

5.8.5 Circulation of Controlled Documents Form accompanies the original documents at the time of circulation 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.

5.8.6 Copies of documents are distributed to the appropriate personnel who sign the Circulation of Controlled Documents Form. The preparation and updating of the SOP is the responsibility of the departmental heads.  

5.8.7 The Quality control documents which have only one copy with Q.C. e.g. SAP and IP and FG Specification SOPs do not require to be circulated.

5.8.8 The QA department is authorized to change batch size or update document format in Batch Manufacturing Record (BMR) in case of any correction or improvement. The Version No. of Batch Manufacturing Record (BMR) advances in the same manner as in other documents.

5.9 ISSUING & AMENDING LEVEL 3 FORMATS

5.9.1 The Version No. of Batch Manufacturing Record (BMR) advances in the same manner as in other documents.

5.9.2 Generation of formats is the responsibility of department heads.

5.9.3 They include a code number on all formats and revision number where practicable.

5.9.4 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.

5.9.5 The formats are changed as per section 5.7.5 and the latest copy is replaced as per point 5.7.6.

5.9.6 The obsolete version of the format is retained in the obsolete documents file.

5.9.7 Copies are allowed for working activities.

5.9.8 List of Control of Records is maintained by respective department Head which includes the Documents title, Code, location, keeper and retention time.

5.9.9 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.

5.9.10 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.

5.9.11 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.

5.9.12 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.

5.9.13 The Backup data of user files and data base files saved on QA/QC Managers Computers and stand-alone computers attached with QC instruments (e.g. HPLC, UV/Visible Spectrophotometer etc.) is taken by IT department.

5.9.14 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 after correction is made. Over-writing, Blanco, or any other means to erase or mask the original entry is not allowed.

5.9.15 All Level 3 Documents will be appropriately filled for record. Production department, Warehouse and QC department will use “Blue” pen for entries; QC department can also use “Red” pen to report rejection if any observed. However, QA Department use “Green” pen for routine work in specified documents i.e. Level 3 formats.

5.10 CONTROL OF EXTERNAL ORIGIN DOCUMENTS

External origin document like the ISO standards will be controlled similar 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/ downloaded as & when required.

 {getButton} $text={Download in Microsoft Office} $icon={Download} $color={Hex Color}