Standard Operating Procedure of Product Change Control in Pharmaceuticals Plant is describe in this post.
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1. PURPOSE
To describe the method for;
1.1 Implementing and controlling all kinds of planned changes in products including equipment, processes, analytical methods, specifications, inprocess controls, raw materials, formulation, batch size, packaging components, and suppliers.
1.2 Reviewing and controlling all kinds of unplanned changes (deviations) in products from standard operating procedures or established specifications during product manufacturing, testing, packing and release.
2. SCOPE
The procedure is applicable to purchase, regulatory affairs, manufacturing and control departments (Quality control & Quality assurance).
3. RESPONSIBILITY
3.1 Any person from Production, Quality control, Quality assurance, Purchase, Regulatory affairs or any other relevant department of Wimits Pharmaceuticals can request a product change on change request form and is responsible for submitting the form to Quality Assurance department.
3.2 The Product change control committee (Executive Director, Production Manager, Quality Control Manager, and Quality Assurance Manager) is responsible for approval/ rejection of the change and decides its significance for follow-up.
3.3 Quality Assurance department is responsible for impact assessment (in collaboration with the person/ department who have raised the change request), assign responsibilities, assure implementation of the change and do follow up according to its significance.
4. MATERIAL & EQUIPMENT
Not Applicable
5. PROCEDURE
A change request may be planned or unplanned.
5.1 Planned Change
5.1.1 Any person from Production, Quality control, Quality assurance, Purchase, Regulatory affairs or any other relevant department of Wimits Pharmaceuticals can plan a change in the product.
5.1.2 Planned change may or may not require deviation.
5.1.3 Reasons for planned change may include;
a. New / additional working practices e.g. changing procedures.
b. Installation of new equipment.
c. Need to update analytical methods/ specifications.
d. Change in batch size/ formulation.
e. RM / PM source change etc.
5.2 Unplanned Change
5.2.1 Unplanned changes are the ones linked to deviation raised on Deviation report.
5.2.2 If deviation is repeatedly observed for subsequent three batches (commercial), then the desired particular change is done permanently.
5.2.3 Deviations serve as the reasons for such changes and may include;
a. System failure/ malfunction.
b. Equipment failure/ malfunction.
c. Replacement of equipment parts.
d. Emergency use of alternative equipment
e. Any change due to product behaviour etc.
5.3 Product Change Control System
5.3.1 The person proposes a change in product, requests it through the “Product Change Request Form. The concerned person after filling the justification & assessment, categorizing the change and proposing an implementation date/Batch # on “Portion-A” of the form informs the Q.A department. Supporting data (if applicable, e.g. in case of any product specification change) is also submitted by the originator to QA department to attach with Product change request form.
5.3.2 Q.A Manager/ Q.A officer assigns a change Reference number on the form and enrolls it in the “Product Change Control Log Book”. The date, product name, implementation batch no., brief description of change, category of change and significance of change are also entered in the log book.
The numbering system followed is PCR/DDD/YY/000 where;
DDD = Department
YY = Year
000 = Serial Number
Example: PCR/QA/15/001
5.3.3 Q.A Manager/Q.A officer then performs an Impact assessment with all concerned personnel involving the Section Incharges, Production Manager & QC Manager if required. Then Q.A officer lists the actions to be taken, person responsible for taking the action along with expected completion date.
5.3.4 On the basis of Impact assessment the acceptance or rejection of change request is decided by the Change control committee comprising of Executive Director, Production Manager, Quality Control Manager, and Quality Assurance Manager. If the impact on product is considered acceptable, the change is approved and on the basis of its significance it is decided that whether its follow-up is Critical, Major or Minor.
a. Critical Changes may include Printed Packaging Material change, Formulation change by API quantity or Excipients change, QC test specifications or Analytical Method change etc.
b. Major Changes can be Permanent Batch size change, Equipment change, Excipients quantity change, Process change, Process parameters change, Supplier change etc.
c. Minor Changes are temporary batch sizes change etc.
5.3.5 Q.A Manager/ Q.A officer informs all concerned department about the action(s) to be taken and taking signatures on Product change request form.
5.3.6 Q.A Manager/ Q.A officer follows up the raised Product Change request as per their significance by reviewing the actions taken.
5.3.7 QA Manager/ Q.A officer ensures that all actions are taken by relevant department before assigned completion dates so that smooth and planned change occurs without any disturbance in product quality.
5.3.8 After completing the assigned responsibility the person(s) responsible for taking the action provides data or references proving completion of the assigned actions.
5.3.9 After confirmation that all actions have been completed, Q.A Manager/ Q.A officer will give remarks and close the Change request by entering the effective date against each assigned responsibility and the actual implementation date of the change in the Product change request form “Portion-B”.
5.3.10 After closing the change request Q.A performs follow up on the change request to check whether the actions taken were effective or not. The follow up is done within one week of closing the product change request form.
5.3.11 Completed change requests are filed in the “Change Request file” in Q.A department.
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