The Cleaning Validation Protocol is an essential part to execute the cleaning validation process.
|Title of Contents|
|ANNEXURE A – Cleaning Validation Test Request Form|
|ANNEXURE B – Cleaning Validation Test Report|
|ANNEXURE C – Cleaning Validation Test Report|
1.0 OBJECTIVE To assure that the cleaning procedure for Equipment removes residues to the extent of compliance with the pre-determined acceptance level. (Sifter As an Example)
2.0 SCOPE: This protocol applies to the Pharmaceutical Manufacturing Facility.
3.0 RESPONSIBILITY: It is a joint responsibility of the Quality Control, Production, and Quality Assurance departments. The detailed responsibility matrix is given below
- Protocol Preparation- Executive QA
- Protocol Approval- Head QA
- Protocol Execution – Head Production
- Sampling as per Protocol – Executive QA
- Testing as per Protocol- Executive QA
- Test result view And approval- Manager QA
- Validation Data Compilation- Executive QA
- Validation final approval- Head QA
Clean the equipment as per SOP “Cleaning of Equipment”.
Sample from the specified sampling points (6.0) as per the sampling plan (5.0).
5.0 SAMPLING PLAN
- Sample from first rinse (after washing with raw water).
- Sample from second rinse (after cleaning with 0.1% liquid soap solution and raw water).Sample from final rinse of purified water.
- Swab (in 2.5 cm x 2.5 cm area) for chemical analysis.
- Swab (in 10 cm x 10 cm area) for bio-burden.
6.0 SAMPLING POINTS
- Upper Hopper
- Sieve used for the batch
- Powder discharge assembly
Note: Sampling points may differ from equipment to Equipment (We used Shifter for Reference)
7.0 TEST / METHOD
- Inspect visually for the absence of previous products in the equipment (sample I)
- Determine the absence of detergents by the froth method (sample-II ).
- Determine the concentration of active ingredient of the previous product in the final rinse (sample III).
- Determine the concentration of active ingredient of the previous product in the swab (sample IV).
- Report and record the above test (1,2,3 and 4) results in ANNEXURE – B
- Determine the bio-burden(sample V) and record the results in ANNEXURE– C
8.0 ACCEPTANCE CRITERIA
- No traces of the powder shall be visible on any part of the machine (sample-I)
- Detergent should not be identifiable by frothing test. (Sample-II).
- The concentration of the previous product should not be more than 10 PPM in the final rinse i.e. (sample III)
- The concentration of the previous product should not be more than 2 PPM in the swab (i.e. sample IV)
- Bio-burden limits are as below (sample V)
- Total CFU – NMT 10 CFU
- E. Coli -absent
- Salmonella – absent
Annexure- A (Cleaning Validation Test Request Form)
Annexure- B (Cleaning Validation Test Report)
Note: Attach calculation sheet and chromatogram.
Conclusion / Recommendations:
Tested by: ______________ Approved by: ________________
(Analyst – QC) (Manager – QC)
Annexure – C (Cleaning Validation Test Report)
Analyzed by: _______________ Approved by: ________________
(Microbiologist) (Manager – QC)