Professional Documents
Culture Documents
• Routine inspection- when non compliance with GMP, not inspected from 3-5years.
• Concise inspection-Manufacturers with a consistent record of compliance with GMP
through previous routine inspections are eligible for concise inspection.
• Follow up inspection (Reinspection)- To monitor the result of corrective actions.(6
weeks to 6 months from initial inspection).
• Special inspection- To undertake spot checks following complaints or recalls related to
suspected quality defects in products.
• The inspection confirm that in process tests were performed as per plans
and results are obtained within specified limits.
Example – weight variation test , hardness test etc.
Classification
Trial run inspection : tools and machines are checked before the operation.
First off inspection : the items produced in the first run are inspected and examined
With respect to specifications.
Inspection by self control : performed by operators, controlling operations at
various levels of operation
Decentralized inspection : semi finished goods are inspected either by machines or
by production line.
Centralized inspection : performed by well experienced operators and highly
sophisticated equipments. Hence this give more reliable results.
Component dominant : incoming material should be inspected for
Required specifications.
Set up dominant : an operation when set up at a level remains at that
level for long time. Hence a produced initially is found free from defects
and following specifications, Then the operation can be cleared for
continuous operation.
Machine dominant : equipment drifts away after continuous operation,
hence they need to be inspected.
Operator dominant : Quality also depend on operator skill.
Information dominant : sop’s
Record dominant : the written records and documentation for each test
and process should be maintained.
These inspections include :
• The specific methodology which will be used to test drug product.
• Complete assessment of laboratory compliance with GMP.
• Specific aspect of laboratory operations.
• Sop’s should be complete and adequate and laboratory operations must comply
with written procedures.
• Specifications and laboratory procedures should be suitable and as applicable ,
in conformance with application requirements.
• Inspections are designed to determine If the data Submitted in the application is
authentic And accurate, And the procedures in application Were used to
Produce the data contained in application.
Material
Method
Man
Machine
• This is also called as pre shipment inspection.
• This is the most popular type of QC inspection For importers.
• IT takes place when all the products are finished and ready for shipment.
• The samples are drawn in a random manner and is representive of whole
batch.
Statistical quality control
It is a technique of controlling quality of product by a set of statistical tools.
It consist of two key elements
1. Statistical process control(control charts )
2. Acceptance sampling(single sampling plan and double sampling plan)
Change control
• Change control is a CGMP concept that focuses on managing
change to prevent unintended consequences. Certain
.
manufacturing changes (i.e changes that alter specifications, a
critical product attribute or bioavailability) require regulatory
filings and prior regulatory approval
4.0 Responsibility :
Primary: Officer / Supervisor of respective department.
Overall: Respective department Head.
5.0 PROCESS
• Components of change control
Following changes are including in change control procedure.
Change in the storage condition of raw material, finished goods, WIP.
Change in Expiry or retest date.
Change in Stability study protocol.
Change in SOP.
Change in protocol.
Change in Batch Manufacturing Record.
Change in Batch Packing Record.
Change in Specification and Analytical Test Method of following:
Raw materials and Packaging materials.
In process and Intermediates.
Finished Products.
Change in drawings.
Change in Utilities.
Change in Manufacturing process including rework and re-processing.
In process controls.
• Any of the changes excluding the changes in specifications, analytical methods,
Master Formula, Batch Manufacturing Records and those changes affecting the
regulatory affairs shall be controlled by the corporate QA.
• The person requesting the change should fill in the ‘Change Control form’ and
submit it to QA In charge through the department head.
• The person requesting the change shall add any reasons or justification with
adequate supporting data for the change to the ‘Change Control form”.
• The Q. A In charge shall evaluate the change proposal considering the necessity
for change and any other GMP aspects that will be affected by the proposed
change.
• If the Q.A In charge has the valid reasons to reject the proposal for change, he /
she can reject the change proposal and intimate the requester about the same.
• The Q.A In charge shall approve the change and shall forward the request to
corporate QA for their evaluation & suggestions if required.
• QA personnel shall coordinate with corporate QA for the
proposed change.
Once the QA department approves the change control
form, the user department shall prepare relevant revised
documents.
The revised document shall be approved by QA in
charge.
User department shall implement the change, based on
effective date mentioned on the documents.
6.0 DOCUMENTATION
• Change control form
• Change control log books.
• BENEFITS OF CHANGE CONTROL SYSTEM
• STRUCTURED AND SYSTEMATIC APPROACH FOR
CHANGE MANAGEMENT WITH PROPER CHANGE
EVALUATION
• DOCUMENTING & TRACKING THE DETAILS OF CHANGE
• ROUTING OF CHANGE REQUESTS TO APPROPRIATE
INDIVIDUALS/TEAM FOR APPROVALS
• DEMONSTRATE COMPLIANCE TO REGULATORY
AGENCIES.