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 89

Method Validation Documentation 89

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: Stability & Method validation / verification analysis hands on experience HPLC/ GC/ LCMS/ ICPMS etc., Date : 7th Jan’ 2023.

Method Validation 52

Method Validation Documentation 52

Pharma Pathway

JANUARY 2, 2023

Sun Pharma-Walk-In Interviews for Analytical Development -R&D On 7th Jan’ 2023. Walk-In Interviews for B.Pharm/ M.Sc/ M.Pharm in Analytical Development -R&D On 7th Jan’ 2023 @ Baroda. Experience in Analytical method validations in GMP environment. Date: 7th Jan’ 2023. Job Description.

Method Validation 52

Method Validation 52

Pharma Pathway

JANUARY 30, 2023

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. Ltd- Walk-In Drive for Freshers & Experienced in Quality Control On 4th Feb’ 2023 Maithri Drugs Pvt. Knowledge and handling of HPLC and GC Instruments activities.

Method Validation 52

Method Validation Documentation 52

epicur

JANUARY 18, 2024

November 1, 2023, marked the effective date of the revised United States Pharmacopeia (USP) chapters <795> and <797> Under these revised guidelines, 503A compounding pharmacies are required to comply with the new beyond-use date (BUD) regulations on their preparations, which are much shorter than what was previously allowed.

Compounding 52

Compounding Compounding Pharmacies Dosage Method Validation 52

GMPSOP

DECEMBER 24, 2023

Laboratory documentation and records that should be available include: – Test methods and test reports – Laboratory notebooks/sheets, instrument records, and calculations – Conditions of tests and instrument settings. – Test method validation protocols, data and reports – Other records and data i.

Documentation 52

Documentation Method Validation Packaging Data Entry 52

European Pharmaceutical Review

MARCH 6, 2024

Additionally, the new laboratory offers Ariceum the ability to carry out on-site process, method, validation and formulation development as well as preliminary stability analysis of its radiolabeled compounds. Internet] European Pharmaceutical Review, Issue 3 2023. 1 References Jaafar-Thiel. cited 2024Mar].

Method Validation 89

Method Validation Clinical Pharmacology Compounding 89

GMPSOP

APRIL 3, 2023

Adapted and non-standard methods must be validated. Protocols are only used for specific projects such as method validation testing or equipment qualification. – Methods for data analysis and interpretation, including the statistical techniques to be used.

Documentation 52

Documentation Method Validation Compounding Data Entry 52

GMPSOP

SEPTEMBER 27, 2023

Cleaning validation protocol for pharmaceutical industry Pharmaceuticals quality assurance & validation procedures GMPSOP Cleaning validation protocol for pharmaceutical industry Last Updated on September 28, 2023 by Kazi Prev PREVIOUS POST Table of Contents What is cleaning validation in pharmaceutical industry?

Method Validation 98

Method Validation Documentation Pharmaceutical Manufacturing Dosage 98

European Pharmaceutical Review

JANUARY 25, 2024

Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. This document is revised from a version published in October 2023.

Documentation 89

Documentation Method Validation Packaging Labelling 89

GMPSOP

NOVEMBER 19, 2023

All validation/qualification studies commenced or completed during the review period must be assessed. The effectiveness of the validation must be determined.

Documentation 52

Documentation Packaging Method Validation Process Improvement 52

GMPSOP

OCTOBER 28, 2023

Validated test method A test method comprehensively describes all procedures used in sample analysis. Analytical test method validation guarantees that your test method is robust enough to provide evidence if your product meets the predetermined product specification or conforms to the failure of a product.

Documentation 52

Documentation Method Validation Packaging Data Entry 52

GMPSOP

JULY 23, 2023

Validation of testing methods: Validate all testing methods used during the qualification process to ensure the accuracy and reliability of results. The other two tests are operational (OQ) and performance qualifications (PQ) which are done successively after the IQ.

Documentation 52

Documentation Method Validation Packaging Labelling 52

GMPSOP

JUNE 16, 2023

Importance of acceptance criteria in analytical method transfer Pharmaceuticals quality assurance & validation procedures GMPSOP Importance of acceptance criteria in analytical method transfer Last modified: June 17, 2023 Table of Contents What is analytical method transfer?

Documentation 52

Documentation Dosage Communication Method Validation 52