Archives: Guidelines

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

Rounding off, Statistics

Refer USP General Notices: USP General Notices: Significant Figures and Tolerances USP General Notices &

Quality Risk Management (QRM)

ICH: Quality Risk Management – Q9(R1) – Final version – Adopted on 18 January 2023

Reserve Samples / Retention Samples

Regulatory Guidelines on Reserve Samples, Retention Samples, Reference Samples, Retention of Bioavailability and Bioequivalence (BA

Quality by Design (QbD) Design of Experi

USFDA, EMA, ICH Guidelines on Pharmaceutical Development for Medicinal Products, Dosage Forms, Drug Substances (APIs),

Qualified person (QP) and Batch release

EU GMP Annexure 16 Guidance’s, Qualified Person (QP), Batch Release, QP Declaration, Templates EU GMP

Process Validation

USFDA: Process Validation: General Principles and Practices – Guidance for Industry European Medicines Agency (EMA)

Method Validations

ICH Q2(R2): Validation of Analytical Procedures; Final Version; Adopted on 1 November 2023 ICH Q(14):

Manufacturing Date and Expiry Date

USFDA – Expiration Dates – Questions and Answers USFDA Inspection Technical Guides: Expiration Dating and