To lay down a procedure to describe the handling of change control which include the procedure for initiation, evaluation, review, approval/ rejection of proposed change, Implementation of the approved changes and its post implementation.
2.1 This procedure is applicable for handling of change control.
- This procedure covers (but not limited to) the change in product quality / reproducibility, facility, utilities and / or support systems, process equipment, / instrument including computer data storage device / software, manufacturing formula, manufacturing / packing process & parameters,
process environment or manufacturing site, standard batch size, specification, analytical methods,
vendor / suppliers, raw / packing material, artworks, process aids, holding period; storage and
distribution of product, documentation including validation master plan, validation reports, qualification protocol and reports, new material / product introduction, SOP’s, site master file.
|Initiating Department||:||Officer/ Executive of initiating department|
|Evaluation||:||Officer/ Executive QA|
|Compliance||:||Head initiating department and QA Head|
Head Quality Assurance: for implementation and system compliance
- Change control is “a formal system by which qualified
representatives of appropriate disciplines shall review proposed or actual
changes that might affect a validated status. The intent is to determine the
need for action that would ensure and document that the system is maintained in
a validated state.” Change is also defined as addition/ deletion in the
existing validated system.
- The proposal for change from the existing system, facility, standard procedures / practices and document updation shall be initiated by the officer / Executive of respective department. The same shall be reviewed by Department head with proper justification for the proposed change and shall be forwarded to QA department for its evaluation based on the justification and supporting data.
- Change control covers the
following criteria but not limited to:
- Facility Related
- Manufacturing Process Related
Changes in batch size, batch formula, manufacturing steps/ instructions, process parameters, in-process controls, primary packing, pack specification and pack size etc.
Change in the specification of Raw materials (including active, excipients, solvent, reagent and catalysts) In-process, Finished Product, Change in Analytical or Microbiological test procedures (STP/GTP), Stability Protocol, Analytical Method Validation (if applicable) and any other which may directly/ indirectly affect the product quality; Changes in Packing Material specification, Art work and other printed packaging material shall be requested to be routed through Change Management process.
Extension of the shelf life based on the available stability data and change in storage condition, Stability Program etc.
- Documentation Related
Change in SOP, formats, Batch Records, Validation Protocol, Stability Protocol, Site Master File, Validation Maser Plan, Quality Manual or any other documents, Changes in drawings related to facility and utilities etc.
Changes in Vendor, source of raw material / primary packing material, Bill of material etc., Changes proposed by marketing based on the feedback from customers. Changes proposed by production department for improving the packing / presentation of the product, changes proposed by Distribution or changes due to change in Registration profiles. Changes due to updation in Pharmacopoeia, changes due to introduction of new guidelines or cGMP requirements. Compliance issues, CAPA practices/ Procedural changes.
- Issuance of Change Control format:
- The format of Change control shall be issued by QA on the written request by respective departments.
- In case of any additional prints/ page are required then respective department shall raise requisition for additional page. QA shall issue additional page.
- Initiation of change control
The change control shall be initiated by the concerned department Officer/ Executive and checked by concern department head. Initiator shall cover the following points:
- Date of Initiation and Initiating Department
- Product / System/ Material / Specification/ Analytical procedures/ Process/ Documents/ Others (if applicable )
- Proposed Change: A brief outline of the proposed change.
- Reason for proposing Change/ Basis / Reference
/Justification/ Rationale (may include, but not limited to the following:
- Regulatory requirement based on guidelines, GMP / GLP improvement, Compliance to audit observation, Capacity enhancement, Expansion / renovation of the facility, man material movement, Process automation, Improvement suggested by marketing department, CAPA taken as the outcome of the investigation conducted, Environmental conditions improvement, personnel skill improvement.
- Necessary supporting documents to justify the proposed change as applicable shall be attached with the Change Control format (if applicable).
- Evaluation of change control
- Numbering of the Change Controls
On receipt of the filled change control format, QA department shall allot a number to the respective change control and shall log in the Change control log format. Every change control shall be allotted a number consisting of eight characters as follows:
Where, CC- Change Control
DC – Department Code
YY – last 2 digit of current Year (19 for 2019, 20 for 2020)
MM – Month (01 for Jan., 02 for February, 03 for March………………….12 for Dec.)
XXX – Serial Number of the change control in respective month.
The first change control occurring in the Quality Control Department in month of March 2019 shall be numbered as: CC/QC/19/03/001.
- QA Head/ designee shall assess the impact of the
change proposal on:
- Product quality/ Systems /GMP.
- Validation/ Qualification
- Process/ Quality Parameter
- Vendor/ Source of material
- Regulatory Aspect
- Pack Specification
- Any other procedural change, which may have reflection of the proposed change.
- The impact of the proposed changes on documents as listed shall also be done (but not limited to) i.e. MFR/ BMR/ BFR/ BPR, SOP, Item codes, Specification/ STP, Validation/ Qualification Protocol/ Validation Master Plan/ Calibration Master Plan/ Cleaning Procedures/ Analytical Method Validation, Stability Program / Protocol, Formats, Drawing (s), facility layouts, Technical Agreement (s), Site Master File, Log books/ records.
- Any other, such as change in batch number
- As part of the evaluation of the proposed change,
identification for the actions as listed below shall also be evaluated:
- Validation Trial/ Experimental Batch Manufacturing
- Qualification (IQ/OQ/PQ)
- Charging product on stability
- Need of training
- Prior Approval/ Information/ Notification to Regulatory Body/ Business Partner/ Key customer (s)/ internal information to other Departments.
- As part of the evaluation of the proposed change, identification for the actions as listed below shall also be evaluated:
- Development of any new procedure / method.
- Based on the evaluation, QA shall
classify the change as Critical/ Major/ Minor.
- Critical :
- Classification of Change
Changes that may have direct or significant impact on product quality such as, but not limited to:
- Change related to
- Change related to primary packing material
- Stability requirements
- Source of API and key excipients
- Change in environmental conditions that affect the product quality and stability.
- Change in cleaning procedure
- Change in manufacturing formulation.
Changes that may have an impact on product quality, termed as Major changes. Such as modification in the facility, Utility systems, addition or replacement of equipment, or any other change which has impact on the product quality and major modifications for enhancement of GMP/ GLP at the site.
Changes that may not have direct impact on product quality, is termed as Minor changes. Such as changes in the recording formats, changes in the site SOPs, improvement in validation documents, change in secondary or tertiary packing material, minor changes in the Equipment, Utility systems, facility for enhancement of GMP/ GLP at the site, changes in specifications (not affecting product quality).
- During review QA Head shall request any further
information/ data supporting the proposed change from initiator if required.
- Based on the review, QA Head shall identify the department / personnel whose comments / opinion or evaluation is required for the proposed change, based on the nature of change. This may include, but not limited to Production, Quality Control, Ware House, Purchase, Marketing, Engineering, Personnel & Administration, Projects or any other as applicable.
- QA Head shall forward Change Control to the initiator for getting evaluation by the identified internal departments/ personnel.
- After completion of the evaluation by all concerned departments, initiator shall forward the Change Control to QA for approval.
- In case the change proposed, requires evaluation / approval from Regulatory Affairs, customer or any other department which is not operating at the site, the site QA shall send the scanned copy of the change control to the relevant department. After evaluation, that department shall give his comment, acceptance or rejection on the format and shall send same back to the respective site.
- Regulatory department shall evaluate the proposed change and shall identify the requirement for the following, prior to approval of change by considering the regulatory implication, if required:
- Notification of change to customer/ Agency
- Obtaining approval of change by customer
- Regulatory filing
- Based on the comments and evaluation done by QA Head, Plant Head or his designee shall approve/ reject the proposed change control.
- In case of disagreements on decision for recommending the change among identified evaluators, the final decision shall be taken by Plant Head with proper justification.
- In case the change is not approved, Plant Head or designee shall give reason for not approving the proposal. The same information shall be updated in the change control log book and the change control format shall be return to department head from where the proposal was initiated.
- Approval of Change
- Implementation of Change
- QA Head shall communicate the same to initiator to implement the approved change.
- Initiator shall refer the details of instructions/ comments/ actions/ documents as advised by QA in Change Control format.
- The relevant
documents shall be revised and approved change shall be implemented.
- Department head shall ensure the implementation as authorized by Plant Head.
- Post Implementation Evaluation
- As per need determined by QA, changes shall be evaluated after implementation to check whether objective of the change has been achieved.
- The initiator department shall submit all supporting data/ information to QA for evaluation.
- If the
data / information of post implementation is found satisfactory, Plant Head
shall authorize for regularization of the change. In case the data /information is not
satisfactory, QA shall advise to return to the original procedure/ practice and
discontinuation of the approved change.
- Closure of the Change Control
After the post implementation evaluation of change implemented, QA Head/ designee shall close the change control after:
- Ensuring results and supporting data
- Completion of the required activities / documents
identified during the evaluation and approval of change.
- The change control log register shall be maintained.
- The filled change control format and change control log shall be kept with QA department.
- Trending of Change control:
- Continuous trending of the change control shall be carried out.
- QA shall carry out the trend analysis for all the whole year change control, at the beginning of the next year. A copy of trend analysis shall be forwarded to Head Quality.
- The trending shall be carried out for the changes to be done as minor, major and critical changes. However the trending of the major and critical changes shall be done, like facility related, document related, product related, Machine related etc.
Trainer : Head – Quality Assurance
Trainees : Staff of all the departments
Master Copy : Quality Assurance
Controlled Copy : Quality Assurance
|Sr. No.||Annexure No.||Title||Format No.|
|SOP||Standard Operating Procedure|
11.0 REVISION HISTORY OF CHANGE
|Sr. No.||Date||Revision Details||Revision No.|