Guidelines4pharma Blogspot Com 2016 12 Procedure For Change Control HTML
Guidelines4pharma Blogspot Com 2016 12 Procedure For Change Control HTML
Guidelines4pharma Blogspot Com 2016 12 Procedure For Change Control HTML
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SOP for Pharma Industry
Tuesday, 13 December 2016
Procedure for Change control
1.0 PURPOSE
To lay down a procedure for monitoring & control of the initiation, review, approval &
implementation of technical changes in operating procedures, specifications, manufacturing
process, analytical testing methods, equipment, and utilities and operating environment.
2.0 SCOPE
This procedure is applicable to the to all the changes, which may affect the manufacturing
process, formula, facility, equipment layouts, equipment design / systems & procedures (test
procedures etc.), specifications. These changes may be implemented due to process, product,
customer requirements Or replacement of change parts of an equipment.
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5.0 PROCEDURE
5.1 For all the changes, prior approval shall be taken from QA (through the Change Control
Procedure), before implementation.
Typical changes, which must follow change control procedure, are given below. Any other
5.2 changes, which are critical in nature or can have direct impact on the product quality, shall also
follow change control procedure.
Master formula / Batch processing & control records.
Manufacturing equipment / Utility equipments / Engineering equipment.
Manufacturing Site / location. Blog Archive
Manufacturing process / process control parameters.
► 2018 (7)
Raw Material specifications & Finished Product specifications and all the standard test
procedures. ▼ 2016 (42)
Modification in Water system / HVAC system / Compressed air system ▼ December (42)
Inprocess specifications / Intermediates specifications / finished product Procedure for good
specification / Method of Analysis. Warehousing / distribution procedures (for raw documentation practices
material / packing material / finished goods, requiring special conditions for storage
and handling). Procedure for destruction of
Personnel & Administration: Any changes in system. packaging material
Initiator who has to propose the change shall approach to Head – QA for issuance of changeProcedure for preventive
maintenance of all Instru...
control form as attached as per Annexure –II.
5.3 Procedure for Log book
preparation.
The QA officer / executive shall allocate a unique sequential number to each CCF and maintain a
Procedure for
logbook including approved as well as rejected change control requests as per Attachment1.
5.4 maintenance/servicing and
verificati...
The CCIF number shall consist of 10 alphanumerical characters e.g. “CCYYYMM001”.
Procedure for Assigning
Manufacturing & Expiry Dat...
5.5 The first two alphabetical characters “CC” shall indicate “Change control form”.
Procedure for Quality Assurance
system
5.5.1 The Third,fourth, character shall always be ‘Year‘012 for the year 2012.
Procedure for procedure for
signature registration...
5.5.2 The next two numerical characters shall indicate the month e.g. ’01, 02, 03…..12’ .
Procedure for handling of
returned Material/products
5.5.3 The last 3 numerical characters represent the unique sequential serial number for the form
documented, Starting from 001, 002, 003 …… 999. In every month serial number again start Procedure for Line Clearance of
Packing.
5.5.4 from 001.eg. January 01….008, February 02…..008.
Procedure for line clearance of
Procedure for line clearance of
equipment & area
Initiation of ‘Change Control Initiation Form’:
Procedure for job responsibility
5.6 The concerned departmental officer / executive / Head shall initiate , by documenting the Procedure for excess materials
changes control form in any of the manufacturing procedures, specifications, manufacturingreturn memo
5.6.1 process / batch formula, analytical testing methods, equipment, utilities and operating Procedure for temperature &
environment. Humidity monitoring
Procedure for Issue and Control of
The initiator shall record the justification for the proposed changes. All the relevant data Batch Processi...
5.6.2 documents, which support the proposed changes, shall be attached alongwith the form. Procedure for control of batch
manufacturing reco...
All the attached data shall be enclosed in the form of Annexures II. Procedure for sanitization of
5.6.3 purified water tank...
All the attachments shall be reviewed & checked by, by the initiating department. Procedure for cleaning of raw
5.6.4 water tank
Review of CCIF: Vendor Qualification and
5.7 Management
The CCIF shall be reviewed by department head / Tech. Director, for necessity / feasibility of the
Procedure for Product Recall.
5.7.1 changes proposed, justification given along with the attachments, and signed off in CCF.
Procedure for handling of market
complaints
The CCF Shall be reviewed by EHS Deptt for safty concern.
Procedure for conducting terminal
5.7.2
inspection on fi...
The completed CCF shall be forwarded to the QA department for approval, prior to the
Procedure for Change control
5.7.3 implementation.
Procedure for self inspection 2 of
2
5.8 Approval of change control initiation form: The HeadQA / Nominee.
Procedure for self inspection 1of 2
5.8.1 The proposed changes shall be classified by HeadQA / Nominee, into following three categories,
Procedure for addition of
depending upon their impact on the product quality. Recovery
Procedure for Annual Product
5.8.2 Review
QA shall review the change control with respect to impact on product quality, necessity/ feasibility
of the changes proposed, rationale / justification of the change & compliance to cGMP along with
Procedure for handling of
the adequacy of the supporting data attached. deviations
Procedure for sampling, storage,
retrieval & destr...
(a) Minor change A change that does not have any impact on the quality of the product and
operating Procedure for sampling &
system. handling of semifinished...
(b)Moderate change A change that is likely to have an impact on the quality of the product, Procedure for HVAC Qualification
but does not
Procedure for document
make any significant change in the final quality of the product. distribution, Control,Stora...
5.8.3 (c) Major change A change that has a significant impact on quality and / or safety of the final
Procedure to investigate out of
product. specification (OOS...
Procedure for batch numbering
5.8.4 HeadQA shall evaluate the CCF for the impact on the quality of the product and shall recommend
system
any additional studies to be carried out (if required), during implementation of change.
Procedure for preparation &
control of site master...
5.8.5 QA may also recommend additional training, to be given to the personnel involved, in case of
Procedure for sampling &
changes in critical procedures. handling of bulk sample
Procedure for equipments and
In case of a change pertaining to the product manufactured for specific customer on contract
machines qualification
basis, prior approval for this change shall be taken from the customer, by sending notification of
5.8.6 Procedure for Inprocess
the proposed change (with justification) and the proposed data shall be generated to support
Monitoring and Control
evaluation of the change. Upon receipt of acceptability from the customer, the change shall be
Procedure for Entry, Exit in
implemented.
production & quality ...
5.9 Procedure for general
HeadQA shall approve the CCF, for implementation, after satisfying himself that the proposed
housekeeping
change shall not have any adverse impact on the product quality / cGMP compliance / regulatory
5.9.1 Procedure for Induction program
compliance, and that all the necessary supporting data, for justification of the changes, has been
and Training of Pe...
attached.
5.9.2 SOP ON SOP
Implementation of Change:
Labels
5.9.3 The changes shall be implemented by initiating department, after approval of the CCF.
Engineering
5.10
5.10 During implementation of the changes, necessary studies shall be carried out & data shall be
Interviews Questions
collected, as recommended in the CCF. New Guidelines
5.10.1
QA SOP
The data generated shall be compiled by the initiating department and forwarded to QA.
5.10.2 Ads
Closure of CCF :
The closure of the change control initiation form shall be responsibility of the Initiator dept. head
5.10.3 & QA head.
QA shall verify whether the recommendations made in the CCF, have been implemented.
5.10.4 The operating Head / Head QA shall together review the data generated during the
implementation of the change control.
5.11 Finally, headQA shall sign the closure of the CCF. The closure of the CCF shall also be recorded
in the CC logbook.
5.11.1
The documents, which are effected by the implementation of the change control, shall be
reviewed / updated, as per the requirement.
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Archival of Change control forms:
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After approval of a change control proposal, the Change control form shall be stored / archived in
QA department, systematically.
6.0 REFERENCES
SOP guideline by D.H. Shah
cGMP Guideline
7.0 ANNEXURES
8.0 ABBREVIATIONS
Abbreviations Full Forms
SOP Standard Operating Procedure
QA Quality Assurance
CCF Change control form
EHS Environment Health Safety
9.0 DISTRIBUTION
Master Copy Head Quality Assurance Department
Controlled office Copy No. 1 Head Quality Assurance Deptt.
Controlled office Copy No. 3 Head Production (Tablet) Deptt.
Controlled office Copy No. 4 Head Production (Liquid) Deptt
Controlled office Copy No. 5 Head Production (External) Deptt
Controlled office Copy No. 6 Head Production (Soap) Deptt
Controlled office Copy No. 8 Head Store Dept.(Main Block)
Controlled office Copy No. 10 Head Engineering Dept.
Controlled office Copy No. 11 Head Store Dept.(External Block)
Controlled office Copy No. 12 EHS Head
10.0 REVISION HISTORY
Authorized
Revision Effective Reason for By
S.No. Details of Change
No. Date Revision (sign &
Date)
1
Annexure I
CHANGE CONTROL LOG BOOK
Date Change Initiated By& Details of Approved Approved Closeout Remark
Control No Department Change / By/On of Change
Control Rejected Control
.
Annexure II
CHANGE CONTROL FORM
1.0 Change Initiation
Change Control Form No. CCIF___________ Date:
Sign &Date of
Requestor
(Department)
Market Domestic Export
If Export Country / Customer Name:
Change related to: BMR Specifications STP SOP
MOA
MOA
Equipment Design / Configuration Analytical
method
Others (give details)
Existing Procedure
Proposed
Change Details:
Justification /
Rationale for Change:
Enclosure (s)
1.
2.
3.
Initiated By/Date Checked By/Date
Concern Dept. Head
Attachments /
Supporting Data ( If
Applicable)
2.0 Evaluation & Assessment of Change proposal by
QA________________________________
________________________________________________________
________________________________________________________
__________________________________________________
2.1 Can the Change be made Permanent: Yes No
3.0 Category of Change: Minor Major Moderate Permanent
Temprovery
3.2 Any validation / Qualification Documents Affected : Yes No
Any Process Affected : Yes No
Any SOP Affected : Yes No
Any System Affected : Yes No
Any Equipment Affected : Yes No
Sign & date:
Head QA
3.3 Training Required: Yes / No
3.4 Training conducted on:
3.5 Comments from Head of allconcern departments including EHS Deptt. which are likely be
Affected by the proposed Change & whether the change is acceptable or not.
Department Comments & change accepted
Yes/No
Sign/Date
Designation
Sign/Date
Designation
If change not accepted, then discuss the reason thereof with concerned department for
not agreeing with the change & inform the requester.
4.0 Implementation of Change:
4.1 Change Control Implemented By:
Name Signature Date
Implemented By
Department Head
4.2 Observations (if any)
4.3 Quality Profile of batches affected (if applicable):
4.4 Specify if subsequent changes required in
a) Documentation
b)Training/retraining
c) Stability testing/Revalidation
4.5 Proposed Change informed to concern Departments:
Department Designation Sign/Date
5.0 QA Review of Implementation & Closure:
_______________________________________________________________
_______________________________________________________________
______________________________________
5.1 All recommendations fulfilled: Yes No
5.2 If No, Justification:
____________________________________________________________________
_
_______________________________________________________________
___________________
5.3 If No: Has the Change been reviewed Yes No
Name Signature Date
Closure Approved By User
Department Head
Closure Approved By Head
QA
at December 13, 2016
Labels: QA SOP
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