European Pharmaceutical Review

JANUARY 26, 2023

The European Medicines Agency (EMA) has published an updated Q&A document regarding ICH M10 ‘Bioanalytical Method Validation and Study Sample Analysis’. The ICH M10 guideline provides recommendations on the validation of bioanalytical assays for chemical and biological drugs and their metabolites in biological matrices.

Method Validation 87

Method Validation Documentation 87

GMPSOP

APRIL 3, 2023

To confirm your test results are trustworthy and unbiased, you would turn to well-designed policies, procedures, guidelines, methods, protocols and all types of records. In other word, you need GMP documentation specially developed and used for your laboratory to guide you through everything you do in the lab.

Documentation 52

Documentation Method Validation Compounding Data Entry 52

Pharma Pathway

JANUARY 3, 2023

Micro Labs Limited-Walk-In Interview for Multiple Positions On 7th Jan’ 2023. Walk-In Interview for Multiple Positions On 7th Jan’ 2023 @ Micro Labs Limited. Skill Set: Microbiology Analytical Activities, Reviewer, QMS documentation and Environmental Monitoring in Sterile manufacturing facility. Job Description.

Method Validation 52

Method Validation Documentation 52

Pharma Pathway

JANUARY 30, 2023

Documents To Be Carried: Candidates are requested to carry updated resume, photocopies of educational certificates, and photocopy of Aadhar card and PAN Card copy. Time and Venue Details: Walk-Ins On 4th Feb’ 2023 from 9:00 AM to 1:00 PM Interview Venue and Work Location: Maithri Drugs Pvt. Maithri Drugs Pvt.

Method Validation 52

Method Validation Documentation 52

GMPSOP

DECEMBER 24, 2023

Additional documents included each month. The points below outline some areas in the codes where G(C)LP regulations are embedded in the GMP regulations and guidance documents. Additional documents included each month. All sampling procedures and plans must be documented. All written and updated by GMP experts.

Documentation 52

Documentation Method Validation Packaging Data Entry 52

GMPSOP

JULY 23, 2023

Installation qualification will provide you with documented evidence that the equipment or system has been designed, developed, supplied, and installed in accordance with design drawings, the supplier’s recommendations, and in-house user requirements. Additional documents included each month. Checkout sample preview s.

Documentation 52

Documentation Method Validation Packaging Labelling 52

GMPSOP

NOVEMBER 19, 2023

Additional documents included each month. If significant trends are identified, they should be documented, and changes should be made to avoid out-of-specification results. The number of batches manufactured, released and rejected should be documented. Additional documents included each month. Checkout sample preview s.

Documentation 52

Documentation Packaging Method Validation Process Improvement 52