GMP & Quality in Biotechnology

These flashcards cover key concepts related to GMP and Quality in biotechnology as discussed in the lecture.

What does GMP stand for in biotechnology?

Good Manufacturing Practice

What are the four categories of ICH guidelines?

Quality Guidelines, Safety Guidelines, Efficacy Guidelines, Multidisciplinary Guidelines

What is the purpose of the European Medicines Agency (EMA)?

To regulate and ensure the safety and efficacy of medicines in the EU.

Which ISO standard series focuses on quality management systems?

ISO 9000 series

What is ICH Guideline Q6B concerned with?

Quality testing of pharmaceuticals.

What does the term 'CQAs' refer to?

Critical Quality Attributes that affect a product's safety and efficacy.

What is the role of the Head of Production in GMP compliance?

Responsible for ensuring each batch is manufactured according to regulatory requirements.

What is the focus of ICH Efficacy Guidelines?

The design, conduct, safety, and reporting of clinical trials.

Define Analytical Validation as per ICH Q2.

The process of proving that an analytical method is suitable for its intended purpose.

What is the significance of the Master Batch Record?

It is the base document for the manufacturing process, detailing the generic manufacturing protocol.

What does 'validation' confirm in the context of drug manufacturing?

That methods, processes, and systems yield expected results reproducibly.

What are 'Excipients' in pharmaceutical manufacturing?

Substances used in formulations that remain in the final product, such as water.

What type of studies do S1A-S1C guidelines cover?

Carcinogenicity Studies.

Describe the difference between 'verification' and 'validation'.

Verification establishes the suitability of test conditions, while validation confirms method suitability for intended purposes.

What is the purpose of the quality management system within GMP?

To ensure quality throughout the manufacturing process and compliance with regulatory standards.

What are Critical Process Parameters (CPPs)?

Key variables that can affect the quality of a product during manufacturing.