Cleaning Validation goal is to guarantee that cleaning procedures are effective in removing product residue, cleaning agent residue, and live microorganisms from equipment surfaces to predetermined acceptable levels, without compromising the quality and safety of other products produced on the same machinery.
- Cleaning Validation Master Plan
- Cleaning Validation Master Plan 2024
- Cleaning Validation SOP
- SOP for Cleaning Validation
- Annexure I
- Annexure II
- SOP for Analytical Method Validation
- Clean Equipment Hold Time Study
- Dirty Equipment Hold Time Study
- Analytical Method Validation for Cleaning Validation
- SOP for Preparation of Cleaning Validation and Hold time shelf life study Protocol & reports
- Cleaning Validation for Oral Liquid (Mefenamic Acid)
- Annexure I
- Annexure II
- Permitted Daily Exposure (PDE) in Cleaning Validation
- Decontamination of steroid residue from the Ointment Facility
- Sketches of Equipment
- Calculation for Equipment Surface area
- Analytical Method Validation Protocol for Pre & Probiotic Capsules
- Analytical Method Validation Report for Pre & Probiotic Capsules
- SOP for Cleaning Validation of Swab Sample
- Protocol cum Report for Visual Detection Limit
- Cleaning Validation Protocol for Cepha Section
- SOP for Cleaning Validation 1
- Flow chart for evaluation of new product introduction at site
- Annexure II Active Ingredient Name in Drug Product
- Cleaned Equipment Hold time study protocol
- Dirty Equipment Hold Time Study Protocol Cum Report
- Dirty Equipment Hold Time Study Protocol Cum Report for Oral Liquid
- Cleaning Validation Protocol
- SOP for Cleaning Validation
- DEHT protocol blank
- Cleaning Validation Master Plan
- Annexure I Cleaning Validation flow chart
- Annexure-II Surface Area Calculation
- Annexure-III Rating Criteria
- Annexure-IV Summary of Toxicological Assessment and HBEL PDE Value of API molecules handled at site
- Annexure VI Decision for Cleaning Validation
- Annexure VII Dose administration as per MHRA Site
- Product Matrix
- Equipment matrix
- Appendix-I for CVMP
- SOP for Cleaning Validation
- Annexure I Cleaning Validation flow chart
- Annexure II Active Ingredient Name in Drug Product
- Cleaning Validation Protocol for Glimepiride Tablets
- Cleaning Validation Report for Glimepiride tablets
- Annexure-I Equipment Detail & Cleaning Procedure
- Annexure-II Calculation for traces of Glimepiride in rinse
- Annexure-III Calculation & Acceptance for traces of Methanol in rinse
- Annexure-IV Cleaning Details
- Annexure-V Swab Sampling location for Microbiology
- Annexure-VI Swab Sampling details Microbiology
- Annexure-VII Result Recording for Microbiology
- Annexure-VIII Swab Sampling location for Chemical
- Annexure-IX Swab Sampling details Chemical
- Annexure-X Result Recording for Chemical
- Annexure-XI Sampling details Methanol Rinse
- Annexure-XII Rinse result record for Methanol
- Annexure-XIII Cleaning Details after Methanol Rinse
- Annexure-XIV Sampling details after Purified Water
- Annexure-XV Rinse result record for Methanol Traces
- Cleaning Validation of Lyophilizer
- Protocol for Cleaning Validation – Production Lyophilization
- Protocol for Determination of Visual Residue Limit
- Installation Qualification for eResidue Application
- OperationaI Qualification for eResidue Application
- Performance Qualification for eResidue Application Version 2.0.0
- SOP for Operation of eResidue Software 2.0.0
- Summary of eRESIDUE Application 2.0.0
- Protocol for Dirty Equipment Hold Time
- Protocol for Clean Equipment Hold Time Study Validation (Oncology)
- Cleaning Validation Protocol (Production Formulation)
- Cleaning Validation Protocol for Active Pharmaceutical Ingredients
- Cleaning Validation Protocol for Blending
- Record of Observations for eResidue Application Version 2.0.0
- List of Masters and Observers Required for Inspection of Visual Residue
- Recording the Visual Inspection Observation on Different Coupons
Hi sir, thanks for the great articles and valuable information. Was requesting for PDE value for the following products : 1) Cerebroprotein Hydrolysate (2) Chlorzoxazone and (3) Clinidipine. Thank you
ok
give some time.
Regards,
Pharmadevils team
sir please incorporate cleaning validation protocol and report for ointment
ok
Hi sir, we are planning for manufacturing carprofen and Dexketoprofen at our site but in this carprofen is veterinary drug and Dexketoprofen is human drug. How to calculate MACO in above situation (i.e maximum dose).
Thanks ,
As per schedule m 2018, you cant manufacture the veterinary drug along with general products, Vet shall be manufactured in dedicated area or else risk assessment shallbe done to prove that there is no cross contamination of veterinary drug with general drugs. Overall you have to do cleaning validation to prove it.
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