Archives: Guidelines

Bioequivalence, Bioavailability (BA/BE)

ICH: Bioequivalence for Immediate Release Solid Oral Dosage Forms (M13A) ICH: Bioequivalence for Immediate Release

Pharmacovigilance

USFDA Guidance for Industry: E2E Pharmacovigilance Planning USFDA: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment USFDA

Specifications and Tests

Guidance’s and References for setting Specifications, Test methods, Acceptance criteria for Drug products (Formulations, Dosage

Storage and Distribution, Transport and

Regulatory guidelines on Pharmaceuticals Storage and distribution, Temperature controlled storage, Temperature mapping, Temperature cycling studies,

Stability & Hold time studies

ICH Q1A (R2): Stability Testing: Stability testing of new drug substances and drug products ICH

Technology Transfer

Regulatory guidance’s on Pharmaceutical Technology Transfer: WHO Guidelines, ISPE Good Practices PDA Technical Report, IPA

Sterile Manufacturing

Good Manufacturing Practices (GMP) guidance’s and regulatory requirements for Sterile manufacturing, Aseptic processing, Sterilisation Process

Standards (Reference standards, Working

USP, EP, USFDA, EDQM requirements for Pharmaceutical Reference Standards, Secondary Standards, Qualification and traceability, WHO

Site Master File (SMF)

EMA – EU Site Master File (EudraLex – Volume 4 – Good Manufacturing Practice (GMP)

Shared Facilities / Dedicated Facilities

USFDA 21 CFR 211.42: Design and construction features.(Pencillins require dedicated facilities) USFDA Guidance: Non-Penicillin Beta-Lactam