SOP QA002: Control of Documents

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	1			Purpose:
				To lay down the procedure for distribution, control, archival and destruction of the documents.
	2			Scope:
				This procedure is applicable for all the documents, which relate to the quality system, manufacturing, testing and control, including documents of external origin used in xxxx (Company Name)
	3			Responsibility:
				Department						Responsibility
				Quality Department						Control, archival, issue, distribution, and destruction of the all the documents used in xxx (Company Name)
				User						Responsible for maintaining the integrity of the document (i.e., the document shall be legible and identifiable).
	4			Abbreviations:
				QA				Quality Assurance
				RF				Record Form
	5			Definitions:
				Same as in SOP for SOP
		6		Procedure:
		6.1		A document shall be controlled at all the stages of document life cycle which includes: preparation, review, authorization, training, retrieval and archiving and destruction.
		6.2		Documents include Quality policy, Quality manual, procedures, specifications, protocols, instructions, records, reports and any other document which is used at xxxx (Company Name) for planning, operation and control of processes. This also includes the document of external origin. Note: Documents of external origin includes all the documents used by xxxx (Company Name) for reference or operation within the preview of Quality System. This may include Pharmacopeias, Standards (National/international), Statutory/Government regulations, Customer documents (Procedures, Designs, Drawings & Layouts, Proposals etc.) and any other document which is not the property of xxxx (Company Name) for operation and control of the system.
		6.3		Document can be in any form or type of medium (paper based or digital).
		6.4		Preparation of Document:
		6.4.1		All the documents shall be prepared by the individuals knowledgeable with the activity and the organization's internal structure. These documents shall be reviewed and finally authorized by the person appointed by Management.
		6.4.2		All documents shall be prepared as per the respective SOPs.
6.5			Authorization of Document: All the documents after departmental review shall be reviewed by Quality Department for completeness, suitability and standard/regulatory aspects. Finally the document shall be authorized by Head QA or any other person designated by management. The original signed copy shall be designated as ‘Master Copy’. The distribution of the document shall be controlled and controlled copy shall be a photocopy of the master copy.
6.6			Training of the Document: After the document has been authorized concerned personnel shall be trained for the document and the training record maintained. The training shall be in the form of questionnaire ranging from 5 to 10 questions. The pass marks shall be 80% or more of the total marks. (1. Document Training Questionnaire Format)  (2. Document Training Record Form)
6.7			Implementation of Document: After the successful training has been imparted to concerned personals the document shall be made effective by putting effective and next revision date and considered as Master Copy. Generally, the effective date of the document must be 2-3 days after authorization to give sufficient time for effective training.
6.8			Revision of Document:
6.8.1			All the documents under the umbrella of Quality Management System shall be reviewed periodically for completeness and applicability. When revision is due the QA or any other person appointed by management shall intimate the concerned department. (3. Intimation for Document Review)
6.8.2			The documents which become smeared, dirty or are ragged shall be changed on need basis. Change in the contents of the document or deletion of the document shall be made through change control procedure.
6.8.3			Documents shall be reviewed every two years (± 60 days) for keeping them updated. Training of the document is required after this revision.
6.8.4			In case the change in Documents is sought in less than two years it should be made through request for document change, if only the change does not affect QMS and does not require retraining. Any change requested which is supposed to have effect on the QMS shall be dealt through change control procedure. (4. Request for Document Change)
6.8.5			A brief description of changes made in the Document shall be given under the heading ‘History’ and the revision should reflect in the header of the document under revision number and supersedes.
6.8.6			The changed document shall only be made effective after the previous version of circulated document is retrieved by Quality Assurance Department.
		6.9		Identification of internal document:
		6.9.1		All documents shall be prepared as per the respective SOPs. The templates for writing any other documents such as protocols, reports etc., are annexed to the relevant procedure or work instruction.
		6.9.2		All the procedures are uniquely identified for tractability and control of the document of that category.
		6.10		Mater list:
				Master list of all the document categories (such as Manuals, Procedures, Records, Protocols etc.) shall be prepared and maintained. The master list shall be reviewed periodically. The master list shall be under the control of Quality Assurance Department. (5. Master List of Documents)
		6.11		Control of internal document:
				Distribution and control of the documents of internal origin is maintained as follows:
		6.11.1		Master Copy: All documents shall be authorized before making them effective by the competent authority as assigned by the management. The copy used for authorization shall be printed in black ink. The authorized (originally signed) document shall be stamped in red ink as ‘MASTER COPY’ on the top right corner of the document. Note: All the documents shall be signed in blue ball-pen ink.
				Note: Documents under restricted circulation (if any) shall be stamped as ‘CONFIDENTIAL’ in red ink on the front side of each page at top corner.
		6.11.2		Controlled Copy: The required number of documents shall be copied from the Master Copy and shall be stamped in colored ink (blue ink) as ‘Controlled Copy’ on the lower right corner of the document and distributed as per the distribution list.
				If a copy of the document needs to be distributed for activity/ operation(s)/ practice(s)/ reference, the photocopies of master copy shall be released on request with proper reason duly authorized by person designated by the management under CONTROLLED conditions. The record for distribution detail of the document shall be maintained in the prescribed format. (6. Request for Document) (7. Distribution of Document)
				The controlled copy shall be dated and numbered chronologically.
				Controlled Copy has a retrieval control and shall be retrieved and destroyed before new version is made available.
		6.11.3		Uncontrolled Copy: Uncontrolled documents are current on date of issue but are not covered by change control. Hence, it must be checked by the user for correctness of information as on date. These are the documents which does not have retrieval control, however if any retrieval is encountered the document shall be destroyed. These documents when issued shall be stamped as ‘Uncontrolled Copy’ (in blue ink) on top right corner of the document.
				The issue record shall be maintained in the prescribed format. (7. Distribution of Document)
		6.11.4		Obsolete Copy: The documents, which have been amended or removed from use, are called obsolete. These are removed from controlled circulation and destroyed. Only one copy is preserved for legal and/or knowledge preservation purposes. The master copy of the superseded document shall be maintained in the documentation cell stamped as ‘Obsolete’ in colored ink (red ink) at the center of each page and filed in a separate file (Obsolete File).
		6.12		Control of Record Forms:
		6.12.1		Records forms are the special type of documents which when filled provides evidence to conformity to requirements and of the effective operation of a system.
		6.12.2		Each type of record forms such as Production activity records, Batch Manufacturing Record form, QC Testing Record Forms and Quality Management Record forms are issued by QA department and issue records maintained as per respective SOP.
		6.13		Control of Log Books:
				The routine operation activity shall be logged in a log books and log books shall be issued to all concerned departments and controlled as per respective SOP.
		6.14		Control of documents of external origin:
		6.14.1		Identification of these documents is controlled by its sources of origin.
		6.14.2		It is the responsibility of the Quality Assurance Department to identify the documents of external origin. Once identified a list of these documents shall be prepared by categorizing them on the basis of source or type of document as per the prescribed format. The list shall be updated annually. The distribution of these documents shall be controlled under the strict supervision of QA Head. (8. List of Documents of External Origin)
				Note: Master copy of all the documents shall be maintained by QA or any other person designated by Management in the documentation cell. The documents in force shall be maintained separately from that not in force (obsolete).
		7		Reporting:
				Annexure 1 to 8
		8		Annexure
				Sr.No		Title								Pages
				1		Document Training Questionnaire Format								1
				2		Document Training Record								1
				3		Intimation for Document Review								1
				4		Request for Document Change								1
				5		Master List of Documents								1
				6		Request for Document								1
				7		Distribution of Document								1
				8		List of Documents of External Origin								1
		9		References:
				10.1	QA/001, Rev 00: Standard Operating Procedure for writing Standard Operating Procedures.
		10		Distribution:
				Master Copy								Archived in Quality Department
				Controlled Copy 1								Quality Department
				Subsequent Controlled Copy								Department making request
11			History:
			Revision Number						Change Summary
			00						None

Company Logo	Company Name
Document Training Questioner
Reference SOP No.		QA/002	Page No.	1 of 1

Training Module		Date of training	Date of Evaluation	Training imparted by	Document No
Title

                                                                                                                       

S. No.	Questions	Answers	Marks
1
2
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5

Trainee	Name	Department	Signature	Date

                                                           

Total Marks			Evaluated by	Q.A. Approval
Marks Scored		Signature
Evaluation status		Date
Remarks, if any

Company Logo	Company Name
Document Training Record
Reference SOP No.		QA/002	Page No.	1 of 1

Document Number:			Document Revision:
Document Title:
S.No	Name of the Person trained	Signature		Date	Training imparted by
1.					Signature	Date
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Company Logo	Company Name
Intimation for Document Review
Reference SOP No.		QA/002	Page No.	1 of 1

S.No.	Document Category		Document Number	Effective Date		Revision No.	Department
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Remarks:
		Issued By:			Authorized By:
Name:
Designation/Role:
Signature:
Date:

Company Logo	Company Name
Request for Document Change
Reference SOP No.		QA/002	Page No.	1 of 1

Department Making Request:
Title of Document:				Document No.:
Change in		Proposed Change (Attach sheet if space not sufficient)
Purpose and Justification:
Retraining Required:
Effect on Established QMS and Process Validation:
	Requested By:		Departmental Approval:
Name:
Designation/Role:
Signature:
Date:
Comments:
Received in Quality Department By: Comments:
Training Required:
Effect on Established QMS and Process Validation:
Change Authorized By: Name: Designation: Signature and Date:

Company Logo	Company Name
Master List of Documents
Reference SOP No.		QA/002	Page No.	1 of 1

Document Category:
S.No	Document Number		Title		Effective Date
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		Prepared By:		Authorized By:
Name:
Designation/Role:
Signature:
Date:

Company Logo	Company Name
Request for Documents
Reference SOP No.		QA/002	Page No.	1 of 1

Department Making Request:
Title of Document:						Document No.:
Number of Copies:
Purpose and Justification:
	Requested By:			Departmental Approval:
Name:
Designation/Role:
Signature:
Date:
Issuing Department:
Comments:
Type of Copy issued: (Tick whichever is applicable)		Controlled Copy			Uncontrolled Copy
Copy Number:
Number of Copies issued:
	Issued By:			Authorized By (MR):
Name:
Designation/Role:
Signature:
Date:

Company Logo	Company Name
Distribution of Documents
Reference SOP No.		QA/002	Page No.	1 of 1

SOP Number:

SOP Title:

Master Copy

Archive at:

Date:

Signature:

Record for Controlled Copy

Sr.No

Controlled Copy No.

Date of Issue

Issued By Signature

Issued to Department

Issued to Signature

Date of Retrieval

Retrieved By

Date of Destruction

Destroyed By

1

2

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10

Record of Uncontrolled Copy

Sr.No

Date of Issue

Issued By Signature

Issued to Department

Issued to Signature

Sr.No

Date of Issue

Issued By Signature

Issued to Department

Issued to Signature

1

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3

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Company Logo	Company Name
List of Documents of External Origin
Reference SOP No.		QA/002	Page No.	1 of 1

Document Category:
S.No	Document No.*	Document Name		Volume	Revision/ Edition	Archived At
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		Prepared By:	Authorized By (MR):
Name:
Designation/Role:
Signature:
Date: