CONTENTS
- Protocol Pre-Approval
- Objective
- Scope
- Responsibility
- Equipment Details
- System Description
- Reason For Requalification
- Site of Study
- Frequency of Requalification
- Non-Conformance
- Tests and Checks
- Sampling Plan
- Checklist of all Tests and Checks
- References
- Documents Attached
- Non-Compliance
- Deviation From Pre-Defined Specification, If Any
- Change Control, If Any
- Abbreviation
1. PROTOCOL PRE-APPROVAL
2. OBJECTIVE
- To provide documented evidence that the Equipment is performing as per the parameter defined in Operational Qualification and that it gives results as per the predetermined acceptance criteria.
- To demonstrate that the system will operate reproducibly and consistently within its operating range.
- To confirm the suitability of the Standard Operating Procedures for all routine activities associated with the system.
- The document also provides the observed and obtained values indicating compliance with the PQ Protocol.
3. SCOPE
- The Protocol covers all aspects of Performance Qualification for the Tablet in Tablet and sealing machine serving at PharmaGuide Ltd.
- This Protocol will define the methods and documentation used to qualify the compression machine for PQ.
4. RESPONSIBILITY
- The Validation Team, comprising of a representative from each of the following Departments, shall be responsible for the overall compliance of this Protocol:
5. EQUIPMENT DETAILS
Equipment Name: Rotary Compression Machine
Equipment Id No :
Manufacturer’s Name :
Supplier’s Name :
Model :
Location of Installation: Compression area
6. SYSTEM DESCRIPTION
- The double rotary tablet machine and its associated equipment are designed to process pharmaceutical products in accordance with cGMP principles. A double rotary tablet machine is used to compress various drugs to produce tablets.
- The turret is driven by an electric motor, via pair of “V” belt pulleys and worm gear drive, and the turret speed is adjustable. All the cam profiles are made of alloy steel, hardened, and ground. All the tablet parameters can be set while the machine is running.
- The cleaning and operator safety are given due attention in the machine design safety system. The following safety systems are incorporated:
- Mechanical guards for all rotating parts.
- Noise pollution is kept under check < 80db.
- Motors are flameproof.
ALSO READ: Manufacturing Defects of Tablets
7. REASON FOR QUALIFICATION
- Scheduled qualification is required as per the qualification schedule and shall be performed according to detailed written procedures with the original qualification parameters and limits used as the evaluation criteria. The qualification studies shall be documented in detail and the results of the studies shall be compared to the original validation results and evaluated to the same extent. If the results are satisfactory, the equipment shall be certified. If the results are not satisfactory the modified system shall require new qualification studies.
8. SITE OF STUDY
Compression area
9. FREQUENCY OF REQUALIFICATION
- Once every two years.
- After any major breakdown or after major modification.
- After the Change in Location
10. NON COMPLIANCE
- In case of any deviation observed during PQ, inform to Head QA for necessary action.
- Document the deviation detail in the observed deviation section.
- The Head QA will study the impact of deviation. If the deviation is acceptable and it does not have an impact on operation as well as on the performance of the machine, prepare a final conclusion.
11. TESTS AND CHECKS
Objective:
- To verify the smooth functioning of the equipment and to determine that the equipment is consistently producing products of pre-determined quality as it was qualified during the performance qualification.
Scope:
- This qualification is applicable for the 51 stn double rotary machine located at the compression area. This document defines that the compression machine functions smoothly & produced quality products.
Procedure:
- Run for at least 3 batches recording all required data and any deviations to the procedure.
Evaluation:
- The ensure the performance of the uncoated product in its final state, the following acceptance limits are set:
- Visual Inspection
- Hardness
- Friability
- Thickness
- Disintegration
- Weight Variation
12. SAMPLING PLAN
- Collect samples from LHS & RHS of compression machine and perform checks for test parameters at:
- Low, optimum & high set speed & Target hardness
- Low & high set hardness at optimum speed.
- Full, half & third Hopper Level
13. CHECKLIST OF ALL TESTS AND CHECKS
Acceptance Criteria: Results should meet the acceptance criteria.
Test Material/Equipment
- Hardness Tester.
- Vernier caliper.
- DT apparatus.
- Friability test apparatus.
14. REFERENCES
- The Principle Reference is the following:
- Validation Master Plan.
- Schedule – M – “Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products.”
- WHO Essential Drugs and Medicines Policy, QA of Pharmaceuticals, Vol-2. Good Manufacturing Practices and Inspection.
- The following references are used to give additional guidance:
- FDA/ISPE Baseline Pharmaceutical Engineering Guide-Volume 5: Commissioning and Qualification Guide, First Edition / March 2001.
- EU Guide to Good Manufacturing Practice, Part 4, 1997.
- European Commission’s working party on control of medicines and inspections documents, Validation Master Plan, Design Qualification, Installation & Operational
15. DOCUMENTS ATTACHED
- Calibration Certificate
- QC Raw Data
16. NON COMPLIANCE
- In case of any deviation observed during PQ, inform to Head QA for necessary action.
- Document the deviation detail in the observed deviation section.
- The Head QA shall study the impact of deviation. If the deviation is acceptable and it does not have an impact on operation as well as on the performance of the machine, prepare the final conclusion.
17. DEVIATION FROM PRE-DEFINED SPECIFICATION, IF ANY:
- All deviations, non-conformances, and out-of-specification results obtained shall be investigated in accordance with corresponding SOP's and documented in the requalification report.
18. CHANGE CONTROL, IF ANY
- Details of change controls initiated during the re-qualification activity shall be documented in the requalification report
19. ABBREVIATION
No. : Number
WHO : World Health Organization
FDA : Food and Drug Administration
CFR : Code of Federal Regulations
cGMP : current Good Manufacturing Practices
EU : European Union
QA : Quality Assurance
PQ : Performance Qualification
mm : Millimeter
Amp. : Ampere
Tags
Qualification
