1.0
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PURPOSE
To lay down a procedure for document and data control to ensure uniformity of the available documentation throughout the organization for proper implementation of Quality Systems.
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2.0
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SCOPE
To prevent the unauthorized changes made to documents prepared at Company name. To laid down and to follow practice respectively with GMP.
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3.0
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RESPONSIBILITY
QA Chemist / QA Officer
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4.0
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ACCOUNTABILITY
Head Quality Assurance
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5.0
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PROCEDURE
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5.1
5.2
5.3
5.4
5.5
5.6
5.7
5.8
5.9
5.10
5.12
5.12.1
5.12.2
5.12.3
5.12.5
5.12.6
5.12.7
5.13
5.13.1
5.13.2
5.13.3
5.13.4
5.13.5
5.13.6
5.14
5.14.1
5.14.2
5.14.3
5.14.4
5.14.5
5.14.5
5.15
5.15.1
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Documents shall be regarded as a legal authentic data of Company name.and shall be controlled accordingly. It is an important component of a company’s quality system.
All practices which are followed up shall be documented as per the requirement of GMP. Any changes made in the document should be done by a person who is well familiar with the department and experienced.
Documents for new product / process should be prepared by concern department.
When the new or modified Specification / Master Formula Record / Batch Processing Record / Manual/Protocol prepared, it should be checked by the Head of respective department. The identified document as mentioned in scope should be checked If there is any correction, correct it and get approval of Q. A. Head.
The After identifying the location of the document, the document is entered in the distribution data base Each document should be controlled and issued by Q.A Deptt.
Each document should have three copies, one Master Copy which is stamped “MASTER COPY’ with green ink.This indicates that they are an official, controlled version of document.
Second is controlled copy which is stamped with controlled copy with blue ink on front side of the page.
Third is Uncontrolled copies shall be issued for following purpose only
a) Training
b)FDA submission
c) As Reference Document
Each page of document should bear name and address of company, name of document, effective date, revision status, page no and total no. of pages, prepared by, checked by, approved by & authorized by.
Each document is prepared using white colored A4 paper and text in “Times New roman’ and in ‘Regular’ font style.
“Controlled” Document
The documents that are distributed to all concerned departments for implementation of system an undergoes revisions or updating on continuous basis shall be made as controlled document. This shall ensure that only current copies are in use and obsolete copies are retrieved .Following document shall be distributed as controlled copy:
General test procedures / Standard Packing Instruction / Bill of Material, Raw Material Specifications, Packing Material Specifications, Batch Processing record.
Log books for equipment shall be controlled by Q.A department by pasting mention below label Front page of log book. The label shall contain the following details.
Controlled copies shall be prepared by photocopying from the master copy of the document.
Every page of controlled document shall have the stamp of “Controlled Copy” in blue ink.
In case of, Specification(s) received from QC Deptt. Photocopy of Specification(s) shall be controlled by putting stamp– controlled copy” in Blue colour at each page.
Qualification Protocols (DQ, IQ, and OQ, PQ) and Validation Protocols shall be used in original and after execution submitted to QA.
Document / Data approval and issue.
Each document or data shall be verified / checked for its approval and authorization prior to their control issue. Controlled circulation list of each Controlled document shall be maintained by Quality Assurance Department as per annexure I.
For this purpose, a record shall be maintained to indicate distribution status of current documents and retrieval status of obsolete documents by Quality Assurance Department as per annexure II.
Availability of appropriate controlled document shall be ensured by Quality Assurance Department.
SOP(s), Specification(s) shall be issued by officer - Quality or his Authorized nominee.
In case of SOP(s) & Specification(s) prepared by concern Deptt. required Copy(s) shall be prepared by photocopying of master copy & put number serially with blue ink required for distribution. Make entry for distribution in register as per specified format.
Specification(s) received from QC shall be issued, as controlled copies shall be entered in register as per the specified format.
Document and Data changes pertaining to production, process and Control procedures
These changes shall be implemented through ‘Change Control System’
Changes to the document and data shall be reviewed and approved by the change control committee as per the Standard Operating Procedure.
Any document undergoing such revision(s) shall have revision history Sheet attached to it. The same shall be replaced for previous master copy. Every such changes such shall be dully entered in the’ document modification form along with date of change, reason for change and the revision no. the change will be designated as major/Minor. Record modification details as per annexure I.
Such revised document shall controlled as per the procedure & shall be forwarded to the controlled copy holder for the replacement of the obsolete documents.
Such obsolete documents shall be maintained with “OBSOLETE” stamp with red colour marked on it. This shall be maintained for history purpose. (Master copies of such obsolete documents shall be maintained by QAD with “OBSOLETE” stamp marked on it). “Obsolete” documents shall be stored separately from current documents
All other retrieved controlled copies of obsolete documents shall be destroyed by tearing off or by incineration process.
Storage document
All document related to batch manufacturing, analysis, training a quality management system shall be retained for a minimum period of 5 years (unless investigation completed) in quality assurance custody.
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6.0
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REFERENCES
NIL
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7.0
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ANNEXURES
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Annexure No.
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Title of Annexure
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Format No.
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Annexure I
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MODIFICATION HISTORY
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QA/011/F01-00
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Annexure I
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DOCUMENT ISSUE LOG BOOK
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QA/011/F02-03
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8.0
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ABBREVIATIONS
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Abbreviations
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Full Forms
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SOP
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Standard Operating Procedure
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QA
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Quality Assurance
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QC
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Quality Control
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GMP
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Good Manufacturing practices
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9.0
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DISTRIBUTION
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Master Copy
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Head Quality Assurance Department
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Controlled office Copy No. 1
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Head Quality Assurance Deptt.
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Controlled office Copy No. 2
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Production (Tablet) Deptt.
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Controlled office Copy No. 3
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Production (Liquid) Deptt
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Controlled office Copy No. 4
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Production (Lotion) Deptt
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Controlled office Copy No. 5
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Production (Soap) Deptt
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Controlled office Copy No. 6
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Ware house Dept.(Main Block)
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Controlled office Copy No. 7
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Ware house Dept.( External Block)
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Controlled office Copy No. 8
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Head Engineering
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10.0
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REVISION HISTORY
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S.No.
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Revision No.
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Effective Date
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Reason for Revision
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Details of Change
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Authorized By
(sign & Date)
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Annexure I
MODIFICATION HISTORY SHEET
Sr. No.
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Modification
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Page No.
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Date of modification
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Signature
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Annexure I
DOCUMENT ISSUE LOG BOOK
Sr. No.
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Name of the Document
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Document No.
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Revision No.
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Issue
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Retrieval
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Remarks
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Date of Issue
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No. of copy Issue
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Issued by/Date
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Received by
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Reason for Retrieval
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Retrieval by/Date
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Destroyed by
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