Pharmaceutical Manufacturing - Practice Flashcards

150 flashcards covering terms, concepts, and processes from Unit 1 to Unit 3 of the pharmaceutical manufacturing notes.

What does API stand for?

Active Pharmaceutical Ingredient.

What does MA stand for in pharma context?

Marketing Authorization.

In pharmaceutical notes, what does 'products' refer to?

All of the drug products manufactured by a drug company.

What does R&D stand for?

Research and Development.

How are Biologics defined in the notes?

Biologics are bacterial and viral vaccines, antigens, antitoxins and analogous products, serums, plasmas and other blood derivatives used therapeutically.

What is a Finished Product?

The medicinal product that has undergone all stages of production, including packaging in its final container.

What are Diagnostic agents?

Agents that assist the diagnosis of diseases and disorders in humans and animals.

How are Drugs defined in this course?

Substances with active pharmacological properties in humans and animals.

What are Ethical pharmaceuticals?

Biological and chemical agents for preventing, diagnosing or treating disease dispensed by prescription.

What are Excipients?

Inert ingredients combined with drug substances to create a dosage form.

What is Pharmacy?

The art and science of preparing and dispensing drugs for preventing, diagnosing or treating diseases.

What is an Active Pharmaceutical Ingredient (API)?

The chemical in the drug which possesses the pharmacologic action.

What is Bulk product?

The final drug product after chemical or biological processing, ready for concentration, drying, and filling into containers prior to dispensing and final filling.

What does cGMP stand for?

Current Good Manufacturing Practices; FDA-defined systems to assure proper design, monitoring, and control over manufacturing processes and facilities.

Name a core department responsible for manufacturing activities.

Production (Manufacturing).

Which department includes Validation and QA activities?

Quality (including Validation).

Which department ensures continuous plant operations?

Operations.

What are the three functional areas of R&D mentioned?

Discovery research, Animal sciences, Bioinformatics.

What do WHO and FDA stand for?

World Health Organization; Food and Drug Administration.

List the stages of pharmaceutical manufacturing steps given in the notes.

Design conception, manufacture, extraction, supply, alteration, packaging, release, storage.

What is the main goal of pharmaceutical manufacturing?

To provide safe, effective and quality drugs.

What does QA stand for and what is its focus?

Quality Assurance; preventative, eliminates process variation and aims for 'Right First Time'.

What does QC stand for and what is its focus?

Quality Control; product-oriented testing to ensure final products meet specifications.

What is Regulatory Affairs responsible for?

Applications and paperwork surrounding regulations before a medicine can be sold.

Name the four departments highlighted in the notes.

Production, Quality, Operations, Research & Development (R&D).

What are the three functional areas of R&D described?

Discovery research, Animal sciences, Bioinformatics.

What are the two main sources of regulatory guidance referenced (without naming specifics)?

Quality System concepts and lifecycle-based quality management (PQS/ICH Q10).

What does the term PQS stand for?

Pharmaceutical Quality System.

What is ICH Q10 intended to do?

Promote a lifecycle-based quality management approach across the product lifecycle.

List key elements of PQS as stated.

GMPs, Management Responsibility, Continual Improvement, Products and Processes, PQS itself, Quality Risk Management, Knowledge Management, Lifecycle Approach.

What is Quality Risk Management (QRM)?

An overall process for assessing, controlling, communicating, and reviewing risks to product quality throughout the lifecycle.

What are the two primary principles of QRM?

Risk to quality should be based on scientific knowledge; level of effort/documentation should match the level of risk.

Name the four steps of the general quality risk management process.

Risk Assessment, Risk Control, Risk Communication, Risk Review.

What is cross-contamination?

Unintended transfer of foreign chemical, microbial, or physical substances to medicines.

List the four sources of contamination.

MAN (Man), MACHINE, MATERIALS, METHODS.

Give an example of MAN-related contamination.

Lack of training, direct contact, inadequate cleanliness, unauthorized personnel, improper gowning.

Give an example of MACHINE-related contamination.

Inappropriate design, corrosion, lubrication residues, improper cleaning, irregular service, defective equipment.

Give an example of MATERIALS-related contamination.

Storage errors, mislabeling, contamination with microorganisms, improper labeling.

Give an example of METHODS-related contamination.

Open manufacturing systems, inadequate cleaning, poor zoning, lack of line clearance.

What is Good Documentation Practice (GDP)?

Guidelines for recording raw data in a legible, traceable, and reproducible manner.

What questions should you ask about every data entry?

Is it true? Is it accurate? Is it timely? Is it legible?

What are two types of documents in pharmaceutical documentation?

Documents and Records.

Name some examples of documents.

Analytical Methods, Batch Records, Bills of Materials (BOMs), COA, CoC, Laboratory Notebooks, Logbooks, Policies, Protocols, SOPs, Test Methods, Training Documentation, Validation Documents (IQ/OQ/PQ), Work Instructions, Product/Labeling Docs.

What is the mnemonic about documentation importance: 'If it isn't documented, it didn’t happen' referring to?

The importance of Good Documentation Practices.

What is Self-Inspection in the pharma context?

An internal audit to identify known and unknown non-compliance; conducted at least yearly by designated competent personnel; findings recorded.

Who should perform Self-Inspections?

Independent, competent personnel from the company (sub-domain experts).

What areas does Self-Inspection typically cover?

QA, QC, Production, HVAC, EHS, IT, Purified Water System, Warehouse, HR, and related areas.

What is UNIT II about?

Pharmaceutical Quality System (PQS) and Eight Quality Systems.

What model does PQS align with in practice?

ICH Q10 model (Quality Management System for the pharmaceutical industry).

What is the purpose of the Quality Risk Management process?

To systematically manage risks to product quality across the lifecycle.

Name the two primary principles of risk management as described.

Scientific basis for risk and commensurate level of effort/documentation with risk.

What are the stages of process validation (three stages)?

Stage 1 – Process Design; Stage 2 – Process Qualification; Stage 3 – Continued Process Verification.

What does Stage 1 (Process Design) involve?

Defining the commercial manufacturing process based on knowledge gained from development and scale-up.

What does Stage 2 (Process Qualification) involve?

Evaluate process design; qualification of facility and utilities; PPQ protocol.

What does Stage 3 (Continued Process Verification) involve?

Ongoing assurance that the process remains in a state of control during routine production.

What does PPQ stand for?

Process Performance Qualification (or Process Qualification) – protocol and execution in Stage 2.

What is the core concept of Technology Transfer?

Movement of formulation and analytical strategies from development to manufacturing sites.

Define Horizontal Transfer.

External transfer of technology across different sites or organizations.

Define Vertical Transfer.

Internal transfer of technology across stages from basic research to production.

List reasons for Technology Transfer.

Form alliances to advance development; find manufacturing capability; partners with marketing/distribution; exploitation in other fields; address lack of commercial capability.

Who makes up the Technology Transfer Team (list roles)?

Process Technologist, QA Representative, Production Representative, Engineering Representative, QC Representative.

What is the role of the Process Technologist in technology transfer?

Central focus for transfer activities; collates donor documentation; feasibility assessment and resource planning.

What is the role of the QA Representative in technology transfer?

Reviews documentation for MA compliance; ensures transfer complies with marketing authorization.

What is the role of the Production Representative in technology transfer?

Reviews process instructions; capacity and safety considerations; alignment with SOPs.

What is the role of the Engineering Representative in technology transfer?

Reviews equipment needs; initiates engineering modifications and maintenance impact.

What is the role of the QC Representative in technology transfer?

Reviews analytical requirements and ensures method transfer to local systems.

What is Process Validation?

The collection and evaluation of data from design through production to show a process can consistently deliver quality product.

What is meant by 'Quality by Design (QbD)'?

A scientific, systematic approach to product development and manufacturing to ensure quality by design.

List the four key components of QbD.

1) Defining the Product Design Goal (QTPP and CQA), 2) Discovering the Process Design Space, 3) Understanding the Control Space, 4) Targeting the Operating Space.

What is QTPP?

Quality Target Product Profile.

What are CQAs?

Critical Quality Attributes.

What is the 'Process Design Space' in QbD?

The range of process parameters over which the product meets desired quality.

What is the 'Control Space' in QbD?

The understanding of process parameters and their impact on quality control.

What is the 'Operating Space' in QbD?

The optimal set of parameters that accommodate natural process variability.

What are the anticipated benefits of QbD?

More efficient development, better FDA submission outcomes, reduced approval times and fewer queries.

What is a Global term for the eight quality systems that contribute to product quality (as per notes)?

Quality systems under PQS (ICH Q10) including QRM, QMS, CAPA, Change Control, Documentation, Training, Auditing, Deviation and Corrective Actions.

What is the relationship between 'Master Formula' and production?

Master Formula provides the baseline formula and instructions for manufacturing a product.

What is the purpose of Batch Records?

Documentation of the manufacturing steps and parameters for a specific batch.

What is a BOM?

Bills of Materials.

What is a COA?

Certificate of Analysis.

What is a CoC?

Certificate of Compliance.

What is IQ in validation terminology?

Installation Qualification.

What is OQ in validation terminology?

Operational Qualification.

What is PQ in validation terminology?

Performance Qualification.

Why is IQ/OQ/PQ important?

To verify that equipment and processes are installed, operate, and perform as intended.

What is GMP?

Good Manufacturing Practice.

What is CAPA?

Corrective and Preventive Actions.

What is a Change Control in quality systems?

A formal process to manage changes that could affect product quality.

What is the role of QA in regulatory compliance during technology transfer?

Ensures documentation and processes meet Marketing Authorization requirements.

What is the significance of 'as per current SOPs' during self-inspection?

Ensures that procedures reflect current regulatory requirements and company standards.

What is the relationship between 'regulatory authorities' and drug safety?

Regulatory authorities oversee drug development, manufacturing, approval, and post-market safety.

What is the difference between a 'document' and a 'record' in Good Documentation Practices?

Documents are procedural/instructional; records are evidence of compliance.

What is the role of 'environmental monitoring' in pharmaceutical quality?

Part of quality systems to ensure controlled manufacturing environments and product quality.

Define 'evidence trail' in validation.

Documentation and data that prove a process leads to consistent and reproducible results.

What does 'validation protocol' refer to?

A documented plan describing how to conduct a validation activity and what constitutes acceptable results.

What is the 'design conception' stage in manufacturing?

Initial idea and concept phase preceding actual production design.

What does 'validation report' include?

Results of validation activities and conclusions about process validity.

What is included in 'validation IQ/OQ/PQ' documentation?

Evidence for installation, operation, and performance suitability of equipment and processes.

What is 'Disintegration testing' an example of?

A QC test for tablets to ensure they break down properly.

What is 'pH testing' used for in QC?

Quality test for solutions to ensure correct acidity/alkalinity.