Document Control, Purpose:
Document Control, To describe the procedure for activities involved in the preparation, control, retrieval and archiving of quality related documents.
Document Control, Scope:
This procedure covers all the documents issued by Quality Assurance and it also includes documents related to regulatory, calibration, qualification and validation activities at XX Pharmaceuticals Limited (Both General & Sterile Block)
Definitions / Abbreviation:
[][]QA – Quality Assurance
[][]SOP – Standard Operating Procedure
[][]XX – Current Version of SOP
Responsibilities:
[][]The roles and responsibility is as follows:
Procedure:
[][]This procedure shall be applicable for all the new documents, which are prepared from the effective date of this document. The existing document shall be modified as per this procedure whenever due for periodic review or whenever they need to be revised on need basis.
[][]The layout of the Quality Related documents
[][]The layout of SOPs, calibration, validations, guidelines, QA policies, and qualification should be as per the respective templates.
[][]Formats: The format can be designed according to the data that is to be entered. The document number along with revision number, concerned document reference number shall be placed at the top of each page of the format.
[][]Validation protocols and Reports: The format and contents are described in the procedure for validation protocols and Reports.
[][]Quality related documents are essential documents, which establish the quality systems, and are required as per Good Manufacturing Practices (GMP).
Batch Manufacturing Record (BMR) & Batch Packaging Record (BPR): The format and contents are described in the procedure for Preparation, approval, distribution, control & revision of Batch processing records according to SOP.
[][]Specifications, Method of analysis & analytical work sheet: The format and contents are described in the procedure SOP.
Preparation, review and approval/ authorization of documents:
[][]All documents (new or existing) are to be drafted by appropriately qualified personnel of the concerned department and submit to the head of the department for checking. Before submission for checking, the responsible personnel shall initiate a draft copy.
[][]The department Head shall circulate the draft document to concern section Heads for checking. All the comments / inputs shall be written directly on the draft, signed and dated by the respective persons.
[][]After the draft document has been commented on by all the concerned Heads, a final checking /review is carried out by the QA department.
[][]If there are changes, a further document is prepared and circulated until the final draft is agreed.
[][]Concerned department then shall prepare the final copy and assign sequential number (in case of new documents). In case of existing documents, only the version number will be changed.
[][]The final document shall then be signed by the responsible staff. All the draft copies are to be destroyed subsequently.
[][]Concerned department Head shall send the approved master copy to QA for distribution or Issuance of controlled copies.
[][]QA shall issue the controlled copy of documents to concerned departments.
Standard Operating Procedures
[][]Follow the previous step
[][]Sufficient time is given between issue date and effective date to enable training of concerned people.
[][]Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs)
[][]After finalization of Manufacturing Record and Batch Packaging Record shall be prepared by Product Development department.
[][]BMR & BPR shall be drafted by Product Development by using relevant template.
[][]Product Development shall send duly signed master copy of BMR & BPR to QA for distribution or Issuance of controlled copies.
[][]QA shall issue the controlled copy of documents to concerned departments.
Specifications, Method of Analysis
[][]Specification: A list of tests, references to analytical procedures and appropriate acceptance criteria that can be numerical limits, ranges or other criteria to which a material must conform to be considered acceptable for intended use.
[][]Test Procedure: Analytical procedures that are to be followed against any test described in method of analysis.
[][]Each material must have unique specifications and test procedures. The test procedure shall give the details of methods to be carried out against each test parameter defined in the specifications.
[][]QC shall prepare final copy of documents and assign sequential number to all specifications, method and analytical work sheet. These Documents shall be prepared, checked and approved by persons as defined in the responsibility.
[][]QC shall send the duly approved master copy to QA for distribution or issuance of controlled copies.
[][]QA shall issue the controlled copy of documents to concerned departments as per previous step.
Qualification and Validation Documents
[][]Concerned Department shall prepare the Qualification documents by using relevant templates.
[][]After finalization of BMR and BPR concerned QA personnel shall be prepared validation documents by using relevant template.
[][]Other qualification and validation documents shall be prepared, checked and approved by persons as defined in the responsibility.
[][]QA shall issue the controlled copy of documents to concerned departments as per previous step.
Distribution or Issuance of Controlled and Uncontrolled documents
[][]All the GMP documents related to the manufacturing plant will be issued by Quality Assurance. The Controlled copies of documents shall be made by Quality Assurance by photocopying the master copy and sealed as
CONTROLLED
Initial………Date..…
=>in blue ink with initial & date of QA Personnel.
[][]If an additional copy of document is required by any department for operational use then Quality Assurance dept. shall issue an additional copy only after written approval from Head of Quality. Such requests shall be obtained through the Request Form as per Annexure – I.
[][]The controlled copies of new documents shall be distributed to the concerned departments and sufficient time should be given before the effective date of the document to enable training of the concerned people.
[][]All formats shall be controlled by QA. The required number of working format shall be copied from control copy by respective department head or his nominee and reconciliation of copied format shall be done by respective department head or his nominee.
Revision of existing documents
[][]Documents such as SOPs, BMR, BPR etc which requires revision due to change control shall be revised by concerned department.
[][]Revised documents shall be given sequential revision No. and controlled by Quality Assurance.
[][]Documents undergoing change due to regulatory requirements / audit Assurance shall also be revised through proper change control by the concerned department.
[][]QA shall distribute the controlled copies of revised documents to concerned departments as per previous step.
Document Archive
[][]All the master documents will be archived at QA end at the document archiving room of both two blocks. At the archiving room, master documents will be kept after recording the archiving no. in the document archive register as per annexure-V.
[][]In the archive room, master document will be kept in a departmental manner as per allocated area for the individual department.
=>Document archive no. will be given as the following format-
=>GDA/XXXX/YYYY
=>Where, GDA represents as General Document Archive. For Sterile block it will be CDA that’s represents as Sterile Document Archive.
=>XXX represents as the Departmental Code as per following List-
[][]Quality Assurance/QA
[][]Quality Control/QC
[][]Engineering/ENG
[][]Production/PRD
[][]Product Development/PD
[][]Microbiology/MICRO
=>YYYY- represents as sequential number which starts from 001.
[][]Document archive room will be lock & key controlled system. Only authorized personnel of QA department will enter in this room for documents preservation. Any other will take authorization from Head of QA to enter this room for document checking or reviewing.
[][]Retrieval or Recall of Obsolete Controlled copies and Superseding of Obsolete Master documents
[][]When the document has been revised following a change request, the older version must be superseded.
[][]Obsolete versions of documents are retrieved and reconciled and entries are made in the specific obsolete register.
[][]All retrieved controlled copies of documents shall be destroyed immediately & recorded.
[][]The Master Copies of the superseded documents along with document change /approval request form shall be archived in the QA department stamped as in Red Ink maintaining the a register.
OBSOLETE
Initial………Date..…
=>in RED ink with initial & date of QA Personnel.
Document Retention
[][]The Retention period of quality related documents is mentioned in Annexure – II.
[][]All quality related documents should be stored securely and safely with controlled access, protected from damage and mutilation. The storage areas and access restriction to the retention of these documents are in the documents archiving room.
[][]The documents related to legal proceeding should be securely kept till the legal proceeding are over.
[][]All documents relevant to quality of the in-house manufactured products must be included in the documents archiving register having a archiving no.
[][]Quality Assurance shall maintain all the Master documents
[][]Responsible Quality Assurance executive shall maintain a log register for taking & re-archiving of documents from Documentation Archiving Room of QAD.
[][]A log register shall be maintained by responsible Quality Assurance executive to archive the Batch Production Records.
Destruction
[][]QA department shall destroy the documents after the retention period is over and maintain a record of the same.
[][]The destruction may be performed by shredding, cutting, tearing, to make the documents non-usable.
[][]A file note will be prepared. A list of documents with sufficient information like document number, effective date, review date etc. (or manufacturing date, expiry date, batch number or lot number of the materials or products etc.) will be attached as an annexure in the file note. Destruction approval will be given by GM, Plant and Manager, Quality Assurance.
Annexure:
Annexure-I: Request for Issuance of Additional Copy of Documents
Annexure-III: Retention Period of Quality Related Documents.
Annexure-III: Document Control Register
Annexure-IV: Log Register for Obsolete Documents
Annexure-V : Document Archive Register