SOP on Change Control

SOP on Change Control

  • Objective :To establish a procedure for controlling and documenting changes. Through the provisions of this procedure, a proposed change shall be evaluated and approved internally on its scientific merit and appropriate external authorization shall be sought for those changes that impact on regulatory submissions.
  • Scope:This procedure shall apply to formulation plant of (Pharmaceutical Company Name) that manufacture, package, test, and store or distribute drug products.
  • Responsibility
    • All concerned personnel shall responsible to follow the procedure mention in this SOP.
    • Concerned Department Heads shall be responsible for compliance of the procedure.
    • Head QA shall be responsible for final approval & closure of change control.
  • Accountability
    • Department Head & QA Head shall be accountable for implementation of this SOP.
  • Abbreviations and Definitions

 

QA:Quality Assurance
SOPs:Standard Operating Procedure
ROW:Rest of World
VMP:Validation Master Plan
STPs:Standard Testing Procedures
GTPs:General Testing Procedures
PMS:Packing Material Specifications
HVAC:Heating ventilation Air-Conditioning
Change Control:Formal review, evaluation and approval of changes to processes, procedures, specifications, analytical methods, vendors, machines, facilities and utilities
Critical:“Critical signifies the category of the change”. A critical change is a change          that has a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of a product as they may relate to the  safety or effectiveness of the product
Major:Major signifies the category of the change” A major change is a change that has a moderate potential to have an adverse effect on the identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product.
Minor:“Minor signifies the category of the change” A minor change is a change that has minimal potential to have an adverse effect on identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product.
Level-1:“Level -1 signifies level of approval required to approve a change” Initiator department and the quality assurance department only e.g. SOPs related to single department like operating procedure of equipment’s, cleaning procedure of equipments, etc.
Level-2:“Level -2 signifies level of approval required to approve a change” Initiator department and all other interlinked departments within the plant e.g. Change in SOPs which are being followed at different departments at plant level.
Level-3:“Level -3 signifies level of approval required to approve a change” Initiator department and all other relevant departments (within plant or outside the plant) including marketing, RA and Quality and Compliance, etc. e.g. Change Controls which include change in specifications / STPs / GTPs / Artworks / License related issues / BMR / process change / Vendor change, etc These type of changes may require company’s R.A. department to ask for approval of regulatory agency(ies) that have impact on regulatory dossiers submissions.
  • Procedure
    • Any change shall be proposed through a form ‘CHANGE CONTROL FORM’ (Refer Annexure-1).
    • Any personnel can propose a change through “CHANGE CONTROL FORM”. Personnel shall fill the details like Initiator department, date, Initiator (Name & Designation), proposed changes along with proper justification (Justification shall include the existing system and proposed system) and shall assess the need of training. Head of initiator department shall assess the type of change and changes required in the interlinked documents and finally countersign on the proposal.
    • Head of concerned department shall categorize the change as “Critical / Major / Minor as per the definition of the changes. Once the ‘Change Control’ form has been signed by the initiator’s department head / designee, the same shall be forwarded to QA department.

Note:  If documents are required from other departments, initiator department shall collect the data and submit along with the filled “Change Control Form” to QA. Refer Annexure-II for indicative data required for any type of proposed change.

  • QA personnel shall evaluate the basic requirements of the change control and assess whether change control requires comments / approval from Level 1 or Level 2 or Level 3 (refer abbreviations and definitions for explanations of Level 1 or Level 2 or Level 3).
  • After assessment QA personnel allocates a unique number to the change control and log the same number in the “Record of Change Control” (Annexure-III). After logging the change control QA personnel shall circulate the change control for approval to different department Heads or designee.

Note: Comments on the change control can be asked from out-stationed departments through email/fax by sending the complete details of change control by any means of communication.

  • QA personnel shall allocate a nine-digit number to the change control form and sign with date. The number shall be in CCFXXX/YY format, where

CCF:Change Control Form

XXX:Serial number of change control i.e. 001, 002, 003, etc.

/ :‘Slash’

YY:Indicate last two digits of the calendar year e.g. 16 for 2016 e.g. the third Change Control for the year 2016 shall have a number of CCF003/16.

  • A new series of Change Control number shall start at the beginning of new calendar year.
  • All the Department Heads or Designee shall evaluate the change control at their respective ends and give their comments (acceptable or not acceptable) on the change control form and submit back to QA department for further action plan.
  • The comments shall be written by concerned / relevant department head or his designee, in his absence only (Refer Annexure-IV for format of list of personnel responsible for approval of change control, this list shall be updated twice in a year on half yearly basis and shall be maintained by QA personnel).
  • After receiving comments from all relevant departments Head QA or Designee shall approve or reject the change controls based on the sound scientific assessment.

Note: If a Change Control is pending for approval for more than 30 working days from the date of login, it is the discretion of Head QA or designee to approve or reject the change control.

  • After approval of change control from Head QA / designee, QA personnel shall send the change intimation to all concerned department heads / designee for planning the implementation of the change control through electronic means of communications.
  • After approval of change control, QA Personnel shall evaluate the implementation of the change control and shall close the change control only after all documents or any activity mentioned in the change control is closed.

Note:  QA personnel shall take the re-evaluation of the change controls after every three months or need based.

  • Different types of data requirements for different types of changes are enlisted in Annexure-II, but not necessarily the requirements shall be limited to this list only. If appropriate, QA head or designee may requisition any other type of data to review the proposed change(s).
  • Approval from different departments shall be sought by Quality Assurance department depending upon the criticality of the change control (Please refer Annexure-IV for details).
  • Incase approval from any specific regulatory agency is required, Regulatory Affairs department shall co-ordinate with concerned regulatory authorities and shall give the comments / approval as per their comments.
  • Forms and Records (Annexures)

    • Change Control Form – Annexure-I
    • Proposed Changes and Data Requirements-Annexure-II
    • Change Control Logbook – Annexure-III
    • List of personnel responsible for approval of change control-Annexure-IV
  • Distribution
    • Master copy –           Quality Assurance
    • Controlled copies- Quality Assurance, Production, Quality Control, Stores, Engineering, & Human Resources.

MFR of Dextromethorphan, Bromhexine, Chlorpheniramine Maleate & Guaifenesin  Tablets (drugsformulations.com)

  • History
DateRevision Number
Reason for Revision
00New SOP

Annexure-I

Initiator Department:                                                                                         Date:
Initiator (Name and Designation):
Proposed Change(s) (attach extra sheet if required):  

 

Justification for Change: (attach extra sheet if required):

 

Category:                      Critical                           Major                            Minor                                 (Tick the appropriate)                                                                  
Changes in Interlinked documents, if any (attach extra sheet if required): 

 

 

Approved By (Initiator Department Head/Designee) (Sign. and Date):
Document Remarks

Yes/No/NA

TypeDocument Name or Number(s)
LicenseDCGI or Local FDA license
BMRDomestic/ ROW/ or any other
Specification(s)Domestic/ ROW/ or any other
STP(s)Domestic/ ROW/ or any other
GTP(s)NA
FacilityNA
SOP(s)Plant/ All formulations
Process validation(s)NA
Analytical Method

Validation(s)

NA
Artwork(s)Domestic/ ROW/ or any other
StabilityDomestic/ ROW/ or any other
Equipment QualificationNA
CalibrationNA
Safety, occupational health and environment aspectNA
Machine change partNA
Any other

Put “NA” where not applicable

*Level of Change Control for approval:     Level 1              Level 2                Level 3          

 (Tick the appropriate)

*Level-1:- Initiator department and the quality assurance department only e.g. SOPs related to single department like operating procedure of equipments, cleaning procedure of equipments etc.

Level-2:- Initiator department and all other interlinked departments within the plant e.g. Change in SOPs which are being followed at different departments at plant level.

Level-3:- Initiator department and all other relevant departments (within plant or outside the plant) including marketing, R&D, RA and Quality and Compliance etc. e.g. Change Controls which include change in specifications/ STPs/GTPs/ Artworks/License related issues/ BMR/ process change/ Vendor change etc These type of changes may require company’s R.A. department to ask for approval of regulatory agency (ies) that have impact on regulatory dossiers submissions.

CC NumberNumber Allotted BySignature with login date
   

Comments from QA:

 

Comments from Production:

 

(Sign /Date) 

Comments from QC:                                      

                                                                                           

 (Sign /Date)

Comments from Engg.:

 

(Sign /Date)

Comments from Others (if required):

 

(Sign /Date)

Comments from RA.:

                                  

(Sign /Date)

Final Comments from QA.:

                                                             

QA Personnel

(Sign /Date)

DISPOSITION BY QA DEPARTMENT
Category:Critical                           Major                            Minor

(Tick the appropriate)      

 

The proposed change(s) is / are accepted / rejected and shall be / shall not be implemented

Remarks: 

 

Re-evaluation of change control required / not required

                                                                                                Head QA/ Designee                                                                                                                                               (Sign/Date)

Re-evaluation done on:                                      by:                                                 Designation:

Documents review and status of implementation: 

 

Remarks:

 

Change Control Closure
Name Designation 
Sign./Date Department 

                                                         Annexure-II

                                      Proposed Changes and Data Requirements

 

Sr. No.Nature of Proposed Change InvolvedData Requirements

 

1.Significant change in method of manufactureEquivalent batch analysis data on 3 batches
Stability data on 3 batches at 40°C/ 75 % RH for at least 6 months and ongoing long term stability data at 25°C / 60% RH
Data on any tested impurities
Manufacturing validation for internal use
Expert comment for changes
2.Change of specification :
a. TighteningUpdated Specification
b.  LooseningUpdated Specification
Batch data on 3 batches
Expert report justifying the change
Dissolution data, if applicable
c. Addition of a new testUpdated Specification
New test methods with validation
d. Update of specificationStability results to agree with specification proposed
3.Change in Control MethodsNew analytical method
Analytical validation for new method
Comparison of results by old and new methods
Justification / Expert Report
Training of analyst on new method
4.Change of equipment typeStatement that there is no change in method of manufacture
Batch analysis data on 2 batches (internal)
Stability protocol (internal)
Equipment Qualification data and comparison with existing equipment.
5.Change of manufacturing siteBatch analysis data on 3 batches separately and presented as Certificate of Analysis from the new site.

A GMP certificate from regulatory authority or government licensing body for the new site

Comparative impurity data
QA approval of new site
Additionally for internal-approval samples, full term stability data, justification
6.Addition of Alternative

manufacturing site

Site Master File
Batch analysis data on 3 batches manufacturing at both previous and new site
A GMP certificate from regulatory authority or government licensing body for the new site
QA approval of new site
7.Formula changes : Change in excipient /coolant /flavour /colour/ active salt

 

 

Qualitative ID tests and specifications for new excipient /coolant /flavour /colour/active salt

Batch analysis data on 3 batches

Stability data on 3 batches at 40°C/75% RH at 6 months and ongoing at 25°C /60% RH

Dissolution data where applicable

Bio-equivalence study or Clinical Expert Report

Qualitative ID tests including colouring matters

Stability data for the whole shelf-life

8.Change of excipient supplierData to show equivalence with existing supplier. Meet old supplier specification
New vendor approval from QA and purchase
9.Change of excipiengradeStability data on 3 batches at 6 months and ongoing to support shelf life

Batch analysis data on at least one full scale

New in-process spec for tablet weight if affected

Expert statement to show that efficacy / safety of the product is not affected

ICH stability guidelines (40°C/75% RH) should meet internal market need.
    10.Update of excipient specification (Compendial)New Specification
11.Change in imprints, embossing or other marking on drug productsNew finished product specification for countries that have registered marking previously

Justification of change

For addition of a breakline, gravimetric validation of tablet, comparative friability and comparative dispersion time.

Notification on package literature as appropriate

12.Change of dimensions of drug productNew finished product spec for countries that have registered dimensions of drug product, previously
13.Addition of ‘in-house test’New specs and test method and validation of test method
14.Change in name of productWhen it is an brand name, declaration in writing is required that after approval, the package leaflet and labeling will be adapted at the same time

When the name is generic name, proof is required that proposed name is in accordance with pharmacopoeia.

15.Change in batch sizeComparative batch analysis data on 2 batches (except where specified in the dossier) and process validation
16.Change in batch release site and

Responsibility

Copy of contract stating who is responsible

GMP audit of new site by Pharmaceutical CompanyPharmaceutical Pvt. Ltd.

17Change in batch release site withCopy of contract stating who is responsible

GMP audit of the site by Pharmaceutical CompanyPharmaceuticals Pvt Ltd.

no change of responsibility
18Change in manufacturer / importer responsible for batch releaseProof that the proposed manufacturer/ importer responsible for batch release is the holder of the appropriate authorization (copy of authorization)

Declaration in writing that after approval the appropriate product information will be adapted by a stated date.

19Change in manufacturing overageStability data on multiple batches
20Change in shelf lifeReal time stability studies at recommended storage temperature and conditions
21Change in storage conditionsReal time data on 3 production batches stored at the proposed storage conditions, in authorized packaging material
22Storage address of finished productProof that the proposed site is appropriately authorized (copy of authorization)
23Change of primary packaging materialStability data on 3 batches at 40°C/ 75% RH for 6 months + ongoing study at 25 °C/ 60% RH
Product / packaging interactions study
Specification of new packaging
Comparative stability with previous packaging
24Change in primary packaging sourcePackaging material specifications and analysis to show equivalence
Vendor Approval from QA and purchase

 

25Change in the quantitative

composition of primary packaging

Product/packaging interaction study
Comparative stability data on the new packaging vs. the old and stability data
Specification of new packaging (if changed)
26Change in test procedure of primary packagingNew packaging specification including validation data

 

27Change in non-primary packagingUpdated packaging description and specification
28Change in pack/ size/ container, shape etc.Updated packaging description and specification

                                                             Annexure-III

                                                Change Control Logbook

Date of Change Control loginChange Control No.Initiator Dept.Change Control

related to

CategoryChange Control approved onReview of ImplementationComments after review of implementationStatus after reviewCompiled by (Sign/Date)
OnBy

                                                             Annexure-IV

                          List of Personnel Responsible For Approval of Change Control

S. No.DepartmentHead of Department1st designee2nd designee

 

 

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About Pharmaceutical Guidanace

Alice is the Author and founder of pharmaceutical guidance, she is a pharmaceutical professional having more than 18 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, and Nectar life Science Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube

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