Cleaning Validation in Pharmaceutical Industry ! WHO Annex 3

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Cleaning Validation in Pharmaceutical Industry
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Profile Summary
• Expertise in establishing audit programs; facilitating & clearing various regulatory internal, external & customer audits; successfully faced USFDA Audit,
• Managed validation functions, including validation strategies & approval of protocols, reviewing documents, SOPs, protocols and prepared their summary reports that led to qualification activity of equipment, water & HVAC systems

#cleaning
#validation
A documented process proving that equipment cleaning procedures effectively remove residues to predetermined acceptable levels.

2. Acceptance Criteria
Scientific limits established for residual product, cleaning agents, bioburden, and endotoxins.
3. #Maximumallowablecarryover ( #MACO )
The maximum amount of residual active substance allowed to carry over into the next product without causing safety or quality risk.
4. #Worst-Case Product
A product selected for cleaning validation because it is hardest to clean (solubility, potency, toxicity).
5. Residue
Any remaining material after cleaning—API, excipient, cleaning agent, microbial, or degradant.
✅ #samplingmethods
6. #Swab Sampling
Using swabs to collect residues from equipment surfaces.
7. #Rinsesampling
Analyzing rinse to detect dissolved residues from equipment.
8. Direct Surface Sampling
Measuring residue directly from equipment without swabbing (e.g., coupons).
9. Visual Inspection
Ensuring that equipment has no visible residue—minimum standard before analytical testing.
✅ Analytical / Method-Related Terms
10. Limit of Detection (LOD)
Smallest amount of residue that the analytical method can detect.
11. Limit of Quantification (LOQ)
Minimum amount of residue that can be quantified accurately.
12. Recovery Factor
Correction factor accounting for % residue recovered by swab or rinse.
13. Specific & Non-Specific Methods
Specific: Detects a particular substance (HPLC, GC).
Non-specific: Measures total residue (TOC, conductivity).
✅ Validation Execution Terms
14. Cleaning Procedure / SOP
Standard operating procedure for performing cleaning.
15. Dirty Hold Time (DHT)
Time equipment can remain uncleaned after use before cleaning starts.
16. Clean Hold Time (CHT)
Time cleaned equipment can remain unused before re-contamination risk.
17. Bracketing
Grouping products or equipment and validating the worst case only.
18. Campaign Cleaning
Cleaning performed between batches of the same product but not between each batch.
19. Initial (Prospective) Validation
Validation performed before commercial production.
20. Concurrent Validation
Validation performed during commercial manufacturing.
21. Periodic Revalidation
Re-performing validation at planned intervals.
✅ Microbial / Bio-Cleaning Terms
22. Bioburden
Number of viable microorganisms on equipment surfaces.
23. Endotoxin
Heat-stable toxins from gram-negative bacteria (important in injectables).
24. Sanitization / Sterilization
Procedures controlling microbial contamination in cleaning processes.
✅ Risk & Quality Terms
25. Risk Assessment
Evaluation of potential contamination risks (FMEA, HACCP).
26. #Cross-Contamination
Transfer of product/residue to next batch or product.
27. Dedicated Equipment
Equipment used for one product only due to toxicity or allergenic risk.
28. Data Integrity
Ensuring accuracy, completeness, and ALCOA principles in cleaning validation records.
If you want, #Pharmexcel can also provide:

✔ A one-page summary
✔ A list of abbreviations
✔ A flow chart
✔ Interview questions on cleaning validation
✔ Examples of MACO calculation
• Quality Due Diligence: Support in evaluation of CMO’s quality systems and compliance
• Review of CMOs quality evaluation of preliminary questionnaire, assessment, apply internal / external intelligence to evaluate and facilitate the site due-diligence meeting / audit and provide input to the management
Master Business Management
Certified ISO Auditor. Certified Post Graduate in Human Resources.
Trainer , Coach, Blogger,
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