article thumbnail

FOPE and PharmaState Academy hosts Session 11 of the PULSE series

Express Pharma

Dr Dikshit discussed the importance of validation in the quality control process, emphasising the need for user requirement specifications for standard equipment. He presented on good practices in quality control, highlighting the importance of appropriate qualifications and experience, and adequate facilities for storage and sampling.

article thumbnail

Rallis India Limited-Walk-In Interview foe Production/ QA/ QC On 29th Jan’ 2023

Pharma Pathway

Sampling of FG/RM/PM Analytical Method Validation & Calibration Date of Interview: 29th Jan’ 2023 Interview Time: 09:00 AM to 16:00 PM Venue Details: Rang Lords Inn Nr.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Rallis India Limited-Walk-In Interview for Production/ QA/ QC On 29th Jan’ 2023

Pharma Pathway

Sampling of FG/RM/PM Analytical Method Validation & Calibration Date of Interview: 29th Jan’ 2023 Interview Time: 09:00 AM to 16:00 PM Venue Details: Rang Lords Inn Nr.

article thumbnail

A rapid microbiological method case study for advanced therapy medicinal products

European Pharmaceutical Review

While both are often utilised, growth-based methods are more common because analysing microorganisms without replication can still present challenges regarding accurate detection. These growth-based rapid methods rely on living and actively metabolising microorganisms to produce by-products that rapid systems can analyse.

article thumbnail

SMi’s 10th Annual Pharmaceutical Microbiology UK Conference

pharmaphorum

Microbiology remains an essential tool for the detection of microorganisms present in biopharmaceutical and pharmaceutical batches. Gain insight the current state of Endotoxin testing, including alternative test methods and strategic approaches to method validation.

article thumbnail

Flow cytometry: advantages in immunotherapy clinical trials

Pharmaceutical Technology

To ensure the quality of FCM assay performance in preclinical and clinical applications, several scientific organizations developed recommendations for FCM instrumentation and method validation. The FDA and/or other regulatory agencies typically request validation reports to evaluate the assay performance for the intended purpose.2,3.

article thumbnail

Validation master plan (VMP) – when and how to create one?

GMPSOP

You can read our article “ Equipment Cleaning in Pharmaceutical ” to explore cleaning validation further. If you need help with complete guidance, please refer to the cleaning validation master plan. Method validation master plan? Create a master plan listing all products, specifications, and test methods.