Document & Record Control SOP

1.0   PURPOSE:

 Purpose of this QSP is to ensure that:
1.1.  All the Quality Management System documents are properly reviewed and approved prior to issue, are available at the appropriate locations, and changes to documents are properly authorized and indicated.
1.2.  All records related to quality management system are properly filed, indexed, stored, retained and disposed.


This QSP is applicable on all the below mentioned QMS documents at GT Pharma

ü  Quality Manual
ü  Quality Policies
ü  Quality Objectives
ü  Quality Plans
ü  Quality System Procedure (QSP)
ü  Standard Operating Procedures (SOPs)
ü  Master Lists
ü  Specifications of Raw Materials, Packaging Material & Finished Products & Reference Standards
ü  Product Master Formula & Packaging Materials Master Formula
ü  Formats, Labels & Records
ü  Documents of External Origin

 3.1      Manager QA/QMR & Officer Quality Management are overall responsible to ensure the implementation of this Quality System Procedure.
3.2       Departmental Head(s) are also responsible to prepare & maintain Document and record according to this Procedure.

4.0    Definitions:

4.1       Aseptic Filling:
                       
Operations whereby the product is sterilized separately, than filled and packed using sterilized containers and closures in critical processing zones.

4.2       Bioburden:

Total number of viable microorganisms on or in pharmaceutical products prior to sterilization.

4.3       Media Fills:

Method of evaluation an aseptic process using a microbial growth medium (Media fills are understood to be synonymous to simulated product fills, broth trials, broth fills etc.) 4.1       Standard
A standard is a document. It is a set of rules that control how people develop and manage materials, products, services, technologies, processes, and systems.
4.2       Document:-
Information & It’s supporting medium.
4.3       Procedure:-
Specified way to carry out an activity or a process.
4.4       Record:-
Document stating results achieved or providing evidence of activities performed.
4.5       Quality Policy
The overall intentions and direction of an organization related to quality as formally expressed by top management.
4.6       Quality objectives
A quality objective is a quality oriented goal. A quality objective is something you aim for or try to achieve.
4.7       Quality Manual
A quality manual is a document stating the company management's intentions for operating the quality system. It includes policies for all areas of the business affecting or affected by the quality system. These policies authorize department managers to implement procedures within the boundaries specified in the quality manual. They also serve to provide a measure for procedures, processes and results.


5.0     FLOW CHART:







6.0     DESCRIPTION:

Good documentation is an essential part of the Quality Management System and, as such, should exist for all aspects of GMP & ISO 9001:2008. Its aims are to define the specifications and procedures for all materials and methods of manufacture and control.

Good Documentation can be implemented by controlling the following steps:-

6.1       Controlled Documents:-

Manager QA/QMR & Officer QM are responsible for the following actions related to QMS documents:

ü  Whenever new Document is originated it should be submitted along with New Document Request (NDR) to quality Management Department & Document Change Request (DCR)  in case of any change in previous document.
ü  Documents should be designed, prepared, reviewed and distributed with care. They should comply with the SOP-QMD.
ü  Documents should be approved, signed and dated by the appropriate responsible persons. No document should be changed without authorization and approval.
ü  Documents should be regularly reviewed and kept up to date.
ü  To ensure that change in revised Procedure, Quality Manual or SOP is indicated by a vertical line on the right margin against the text, which has been revised.
ü  All newly created documents shall have revision no. “0” and date of issue. Subsequent revisions shall be serially numbered as Revision No. 1, 2, 3, ……….. and given the effective date for new issue.
ü  Maintain Master Lists (F-01-01) of all controlled documents with their current revision number & effective date should be maintain by DMRs of each department and submitted to Quality Management Department.
ü  Ensure that all new originated & revised documents are distributed to their concerned personnel with their signature on Document Distribution Record.
ü  Retrieving obsolete documents, destroying all except those copies which Quality Management Representative may decide to retain for historical record. Such copies will be stamped as “OBSOLETE ”
ü  Documents maintained in electronic media are saved & protected by backup on central file server & alternate media maintained by M.I.S. Department.


6.2       Documents of External Origin

ü  Documents such as Standards, Pharmacopoeias, Specifications and Rules & Regulation etc. are of external origin used as a reference in GT Pharma should be a part of master list of documents & their distribution is controlled.
ü  These documents are updated when:
ü  The originator of the document informs of a change or revised edition directly or through a notification in the medical / pharmacy / cosmetics publications. The new edition is purchased from the market.
ü  In case of QMS Standard, GMP Cosmetics ISO 22716:2007 certification body notifies about revised edition for procurement.
ü  In case of cGMP (Pakistan) the Ministry of Health, Pakistan informs of a revised issue / edition directly or through newspaper / magazines. The revised edition is purchased from the market.
ü  In case of the pharmacopoeia the latest version available in the market is maintained.
ü  Copies of Master Formula & testing specifications of customer products manufactured are also maintained.

6.3       Control of Records

ü  Personnel designated in QMS documents are responsible to ensure the maintenance of QMS records.
ü  Record filled should be legible and completely filled & signed by personnel designated on form.
ü  Record maintained should be clear, legible, indelible & stored in suitable racks / cupboards in the designated department as required by each procedure.
ü  Records should be made or completed when any action is taken and in such a way that all significant activities concerning the manufacture of products are traceable.
ü  Record should be stored at a location where they do not deteriorate due to water, humidity, dust, sunlight or any other adverse condition.
ü  All records shall be retained for a period specified in the relevant Procedure / SOP or Manual.
ü  The designation / dept. responsible for maintaining the records in each procedure shall evaluate & review records once every year for:

§  any damage or deterioration
§  disposal of records that have outlived their defined retention period

ü  Record completed it’s retention period should be reviewed / disposed on Review of Record  shall be submitted to the Manager QA/QMR by each department.
ü  Where contractually required or authorized by GT Pharma Management, the quality records shall be made available to the Customer or his representative.




1.1  QMS – ISO 9001:2008
1.2  GMP – WHO Guidelines
1.3  Cosmetics GMP- ISO 22716:2007


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