article thumbnail

Hetero Labs Limited-Walk-In Interviews for AR&D/ FR&D/ Analytical DQA On 28th Jan’ 2023

Pharma Pathway

Hetero Labs Limited-Walk-In Interviews for AR&D/ FR&D/ Analytical DQA On 28th Jan’ 2023 Job Description Hetero Labs Limited is one of India’s generic pharmaceutical companies and the “world’s largest producer of anti- retroviral drugs”. Dear, Greetings from Hetero…!!

article thumbnail

Overview of pharmaceutical quality control steps and implementations

GMPSOP

Test method validation in quality control Analytical Method Validation for Quality Control Test method validation generally means the same as analytical method validation, where the terms are interchangeable. Maintenance programs must be documented for laboratory equipment.

Insiders

Sign Up for our Newsletter

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

article thumbnail

Cleaning validation protocol for pharmaceutical industry

GMPSOP

Cleaning validation, including analytical method validation, should be conducted for the new product. Validate analytical method for cleaning validation After selecting the worst-case product check if an analytical method is validated for that product. Additional documents included each month.

article thumbnail

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

GMPSOP

Regulatory authorities require them to produce evidence that the processes and systems are validated, critical equipment is qualified, and manufactured products are tested for purity. Pharmaceutical companies are accountable for properly warehousing, shipping their products, and guaranteeing their stability until expiry.

article thumbnail

Concept of validation in pharmaceutical industry

GMPSOP

Additionally, validation includes continuous monitoring and re-evaluation to ensure that the product or process remains in compliance with the established requirements. By implementing robust validation protocols, pharmaceutical companies can ensure that their products are safe, effective, pure and of the highest quality.

article thumbnail

Overview of GLP requirements on everyday laboratory operations

GMPSOP

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.

article thumbnail

What are the elements of quality control process in pharmaceuticals

GMPSOP

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.