Data Control

1. Purpose :
§ To establish a procedure for writing, approval, issuance, controlling and distribution of documents and data control.
§ To ensure that only the most recent revisions of documents are available at point of use.
§ To ensure that any change in a document is recorded and that all appropriate documentation is updated to reflect the change.

2. Scope :
All quality system documents and records.

3. Responsibilities
3.1. Management representative
3.1.1 Oversees the control of all documents, by keeping a master list of the location of all documents.
3.1.2 Responsible for reviewing the change proposal form (MR/4/003), and informing the originator in case of rejection / approval of change proposal.
3.1.3 Ensures the availability of the documents at proper location.
3.1.4 Provides the document change control training.
3.2. document users
3.2.1 To verify that document / data being used is current by consulting the control documents master list (MR/4/001).
3.2.2 Any user of the document can request a change to a document.
3.3 Plant Engineer, HR Manager, Production Manager ,QA Manager are Functional Authorities for Maintenance Department, HR Department, Production Department and QA/QC Department respectively While Director Finance & Administration will be Functional Authority for Sales Section, Purchase Department and M.R.
4. procedure
4.1. document hierarachy
4.1.1 The documents of the Quality System are categorized into four levels:
4.1.1.1 Level 1: Quality Manual, Quality Policy, Quality Objectives and Organizational Chart.
4.1.1.2 Level 2: Job Descriptions, Quality Procedures, and Standard Operating Procedures.
4.1.1.3 Level 3: Specifications, Testing Methods, Operating Instructions, and Flow Charts, etc.
4.1.1.4 Level4: Formats and Quality Records.

4.2. document Identification (level i, ii, and iii)
4.2.1 Documents of Level I, II and III, excluding the Quality Policy, Validation Protocol and Validation Report will be uniquely identified using the following format:
Medicraft Pharmaceuticals (Pvt) Ltd. Peshawar
ISO No.
MR/2/001

Title: Mention title of Document
Issue
2
Supersedes
Issue 1 of MR/2/001
Effective Date
August 2004
Revision Date
July 2006
Page No.
1 of 10

*AAA = Deptt. code.
BBB = Section Code (Section code is applicable to a document whose scope is section- wide. eg, if a procedure is applicable to Injectable section only, its ISO No., must include its section code (AAA-BBB/C/DDD). But if a document is applicable to whole production deptt., then its ISO No. (AAA/C/DDD) will include only deptt. code.)
C = Level of the document, ie., 1,2,3, and 4.
DDD = Document Number.
Approved codes of deptt./section are:
S.No.
Department/Section
Abbreviation
1
Management Representative
MRC
2
Production
PRD
3
Injectable
INJ
4
Tablet
TAB
5
Liquid
LIQ
6
Dry Syrup
DSS


S.No.
Department/Section
Abbreviation
7
Capsule
CAP
8
Human Resource
HRD
9
Research and Development
RDD
10
Store
STR
11
Raw Material Store
RMS
12
Packing Material Store
PMS
13
Finished Goods Store
FGS
14
Quality Assurance
QAD
15
Quality Control
QCD
16
Sales and Marketing
SAL
17
Maintenance
MNT
18
Purchase
PUR
19
Printing
PNT

4.2.2 Quality manual, Job Descriptions, Validation Protocols, Validation Reports and Validation Master Plan are exceptions to the coding rule of 4.2.1, whose ISO No. will be as:
QM/1
JD/2/DDD
VMP/2
VR – AAA/3/DDD
VP – AAA/3/DDD

Where AAA is Deptt./Section Code, as mentioned in the above table, and DDD is the document number.
4.3. document structure (Level I, ii and iii)
4.3.1 Level II and III documents, except Job Descriptions, specification and Testing Methods, Validation Master Plan, Validation Protocol, and Validation Report will contain the following headings, with accompanying detail necessary, to perform the related procedure:
4.3.1.1 Purpose
4.3.1.2 Scope
4.3.1.3 Responsibilities
4.3.1.4 Definitions (Optional)
4.3.1.5 Procedure
4.3.1.6 References (Optional)
4.3.1.7 Related Documents
4.3.1.8 Annexure
4.3.1.9 Change Control History
4.3.1.10 Distribution List
4.3.2 All the pages of Level I, II, and III documents will bear following additional information duly signed by an authorized persons:
4.3.2.1 Written By
4.3.2.2 Reviewed By
4.3.2.3 Checked By (Not applicable for MR Documents)
4.3.2.4 Approved By (Applicable for Q.A, Q.C, Production and Maintenance Department’s documents)
4.3.2.5 Authorized By ( Not applicable for Quality Assurance and Quality Control
department’s documents).
4.4. document prepartation (Level i, ii, iii and iv)
4.4.1. Management Representative, in consultation with Plant Manager and senior management, will prepare Quality Policy and Quality Objectives for the organization.
4.4.2. Deptt. / Section Head will develop a document, although he / she can assign this task, by consulting concerned Manager, to other person who has the competency to perform the task.
4.5. document review, checking, approval and authorization
4.5.1. Documents related to Production Deptt., M.R., Maintenance Deptt., Human Resource Deptt., QA Deptt., QC Deptt., Purchase Deptt., and Sales Deptt., will be reviewed by the Manager Production, Management Representative, Plant Engineer, HR Manager, QA Manager, QC Manager, Finance Manager and Distribution Manager respectively.
4.5.2. MR will check all the documents for its compliance to QMS requirements.
4.5.3. QA Manager will have the authority to approve the technical documents of the Production, Maintenance, QA and QC Deptt.
4.5.4. Plant Manager/designee will authorize the documents approved by QA Manager.
4.5.5. Authorization of documents related to MR, HRM, Purchase Deptt., and Sale Deptt, will be given by Director Finance& Administration/ Director Marketing.
4.6 issuance of documents
4.6.1 Management Representative will keep a copy of all the documents in a Central Quality File and will distribute controlled copies to the concerned deptt./section, in according with distribute list.
4.6.2 All the original documents are printed, preferably, on white A4/Legal Size Paper.
4.6.3 Controlled documents are stamped in red as “Controlled Copy” by Management Representative for identification.
4.6.4 Uncontrolled copies are allowed only for use by external parties, e.g. customers, auditors, consultants etc. These are stamped in red on the front page as “Uncontrolled Copy”. MR will have the authority to issue Uncontrolled Copies.
4.6.5 MR centrally controls the issuance of documents by maintaining a controlled documents Master list, MR/4/001.

S. No.
Level
Document Type
Issuance Detail
1
Level I
Quality Manual
Restricted only to MR, and users authorized by the CEO or MR.
Quality Policy and Organizational Objectives
Issued to all Departments.
2
Level II
Quality Procedures and SOPs
Issued to concerned Department/Personnel.
Job Descriptions
3
Level III
Operating Instructions
Issued to concerned Department/Personnel.
Testing Procedures and Specifications, Specifications, etc.
4
Level IV
Quality Records and formats
Issued to concerned Department/Personnel.
Documents of external origin
4.7 Quality records and formats (level iv)
4.7.1 Quality records have a limited extent of control, only their format is controlled.
4.7.2 Quality records are uniquely identified by their name and ISO No.
4.7.3 In cases where it is feasible, the format of the level IV documents, except log books and registers ,will be as:

Medicraft Pharmaceuticals (Pvt) Ltd. Peshawar
Page No.
x of y
Title: Mention Title of the Document
ISO No.
AAA-BBB/C/DDD
Issue
1
Effective Date
April 2004

4.7.4 MR maintains a Quality Record List which describes the following information:
4.7.4.1 Record Name
4.7.4.2 Keeper and Location
4.7.4.3 Retention Period
4.7.4.4 Issue No.
4.8 amending documents and records
4.8.1 For amending documents procedure for change control is followed.
4.9 Withdrawl of obsolete documents
4.9.1 Obsolete documents are identified by MR and are duly stamped in red as “Obsolete Document”.
4.9.2 All copies of obsolete documents are withdrawn by MR. One copy of the obsolete document, along with its Circulation Record (MR/4/002) is kept for reference purposes, in an Obsolete Document File, MR/4/004. All remaining copies are destroyed by MR.
4.10 documents of external origin
4.10.1 Documents of external origin are stamped in red as “For Reference Only” and is issued to concerned deptt. and person only.
S. No.
Document of External Origin
Document Type
1
Guidelines
Layout Standards, Reference Templates, Guidelines on GMP,
Quality Auditing, Guidelines for Objectives
2
ISO Standards
ISO 9001:2000
3
Official Reference Books
BP, USP, and other official books etc.
5 related documents
Nil
5 related records
5.1 Controlled Documents Master List, MR/4/001.
5.2 Circulation Record, MR/4/002.
5.3 Change Proposal Form, MR/4/003.
5.4 Obsolete Document File, MR/4/004.
5.5 Amendment Sheet, MR/4/017.


6 annexure
6.1 Flow Chart for Amending Document


ANNEXURE 7.1
Flowchart for Amending the Document

4.8.1
Start
Originator

Identifies and initiates need for changing documents through CPF.







4.8.3

MR and Concerned Deptt./ Section head review CPF

Accepts ?
MR and Concerned Deptt./Section Head

Identifies reason CPF was not approved

No 4.8.2






Yes


Author of Document evaluates the Change Proposal

Approves ?
Author of Document

Informs MR for reason of CPF rejection. 4.8.5 4.8.4

No





Yes



4.8.6
MR

Revises his copy of document manually and informs the originator and all concerned section/deptt. head.







4.8.9 4.8.7
MR

Notifies the Originator
Concerned Deptt./Section Head

Manually amends the document.







MR

Verifies amended changes after about 1 week. 4.8.8





End






Note: In this flow chart document means Level I, II, III, and IV documents, and number written on a rectangle shows the section no. of this procedure.

5.6.1 For Permanent change:
5.6.1.1 Changes required are raised on a Change Proposal form (MR/4/003) along with a copy of suggested changes (if required) and is submitted to Management Representative.
5.6.1.2 Management Representative will discuss and evaluate proposed changes, in consultation with concerned deptt./section head.
5.6.1.3 If they reject proposed changes, MR will notify the originator about rejection of CPF along with the reason of rejection.
5.6.1.4 In case Change Proposal is accepted, MR will forward the proposal for final approval to functional authority who has written the document or holds the authority to approve the concerned document.
5.6.1.5 If change proposal was rejected by functional authority, he will inform MR about the reason of rejection of CPF.
5.6.1.6 Once the change proposal is approved, MR will:
5.6.1.6.1 In case of a major change whole document will be revised with the new issue number by following guidelines given in section 4.4 and 4.5.
5.6.1.6.2 For minor changes M.R. will amend the document in his control, and will inform the originator and concerned deptt./section head about the changes.
5.6.1.6.2.1 Concerned deptt./section head after getting information from Management Representative will make the proposed changes in the document manually.
5.6.1.6.2.2 After about one week, MR will verify the proposed changes by visiting the deptt./section using the amended document.
5.6.1.6.2.3 The newly amended document will carry the new revision no., i.e., revision 1 will become revision 2. In case of level IV documents instead of revision no., issue number will change.
5.6.1.6.2.4 After three revisions next issue of the document will be issued.
5.6.2 FOR TEMPORARY CHANGE
5.6.2.1 For temporary change procedure for change control is followed.
5.6.2.1.1.1