Quality Assurace of medicines

Question 1

What is GMP?

Answer 1

Good manufacturing practice (GMP) is the minimum standard that a medicines manufacturer must meet in their production processes. Products must:

be of consistent high quality
be appropriate to their intended use
meet the requirements of the marketing authorisation (MA) or product specification

It is making sure every time product is manufactured the product is made in the same way and has same quality/use.

Question 2

What is GDP?

Answer 2

Good distribution practice (GDP) requires that medicines are obtained from the licensed supply chain and are consistently stored, transported and handled under suitable conditions, as required by the MA or product specification.

Question 3

What is GCP?

Answer 3

Good clinical practice (GCP) is a set of internationally-recognised ethical and scientific quality requirements that must be followed when designing, conducting, recording and reporting clinical trials that involve people.

Organisations that may have to comply with GCP include:

pharmaceutical companies
contract research organisations
universities
NHS hospitals
charities
GP practices
laboratories analysing samples originating from a clinical trial (including NHS, academic and commercial laboratories)

Question 4

What is quality assurance?

Answer 4

the maintenance of a desired level of quality in a service or product, especially by means of attention to every stage of the process of delivery or production.

Question 5

What is quality?

Answer 5

1. Quality in the manufacture of medicines refers to the extent to which a pharmaceutical product consistently meets the intended specifications and requirements for its identity, strength, purity, and potency. This encompasses all aspects of the manufacturing process, including the sourcing of raw materials, development of the formulation, manufacturing process design, and packaging and labeling.
   To ensure quality in the manufacture of medicines, pharmaceutical companies must adhere to strict regulations and guidelines established by regulatory agencies such as the FDA (U.S. Food and Drug Administration) and the EMA (European Medicines Agency). These guidelines outline the standards for good manufacturing practices (GMPs) that companies must follow to ensure the quality and safety of their products.
   Quality in the manufacture of medicines also involves rigorous testing and quality control measures throughout the manufacturing process, including testing of raw materials and finished products, in-process controls, and batch release testing. This helps to ensure that each batch of product meets the required quality standards before it is released to the market.
   Overall, ensuring quality in the manufacture of medicines is essential to ensure patient safety and to maintain public confidence in the pharmaceutical industry.

Question 6

What is QA?

Answer 6

Wide range of concepts which covers all matters which individually or collectively influence the quality of the product. It is the sum total of the organised arrangements made with the object of ensuring that medicinal products are off the quality required for their intended use. Its everything you do within the organisation to ensure what is produced by that organisation is a quality required.

Question 7

What is Quality Control?

Answer 7

The part of the GMP which is concerned with sampling, specifications and testing, and with the organisation documentation and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor products release for sale or supply, until their quality has been judged to satisfactory.

Quality control function tests all the materials, products made to ensure the correct standard.

Question 8

What is GLP?

Answer 8

GLP – Good Laboratory Practice.
Documentation of any work carried out during the development and evaluation of medicines.
Documentation of analysis of the medicines during and following completion of the production process

Question 9

What is GCP?

Answer 9

GCP – Good Clinical Practice.
Following documented procedures during the clinical evaluation of the medicine.
Documentation of the evaluation of the medicine and any effects experienced by the trial participants.

Question 10

What is GMP?

Answer 10

GMP – Good Manufacturing Practice.
Following documented procedures and using the correct materials to produce a medicine which meets the specifications as approved in the Manufacturing Authorisation Documentation and Marketing Authorisation (Product Licence).
Ensuring all actions taken during the production process are documented and witnessed.

Question 10

What is GMP?

Answer 10

GMP – Good Manufacturing Practice.
Following documented procedures and using the correct materials to produce a medicine which meets the specifications as approved in the Manufacturing Authorisation Documentation and Marketing Authorisation (Product Licence).
Ensuring all actions taken during the production process are documented and witnessed.

Question 11

What developments are in the QA system?

Answer 11

1 Quality Assurance department.
2 All departments.
3 Development department.
4 Production department.
5 Quality Control department.

Question 12

What procedures are taken to ensure QA is followed?

Answer 12

Put written systems in place to control ALL aspects of medicine development, production, evaluation and distribution.
Ensure written procedures are followed (SOPs).
Ensure training for staff is adequate and kept up to date (training records).
Ensure facilities are suitable and maintained in such a state (validation documentation).
Ensure all aspects are checked on a regular basis to maintain compliance with written systems (audit).
Ensure any such audits are documented.
Ensure documentation and any other components are retained for the required length of time.

Question 13

What are the QA systems ?

Answer 13

ISO9000 - Generic Quality Standard.
Applicable across all industries and environments.
Compliance assessed by ISO.
Voluntary compliance, applicable worldwide.
To show compliance with a standard.

IS-IDMP

Pharmaceutical QA systems

Question 14

What are the methods of quality improvement?

Answer 14

TQM (Total Quality Management) - integrated effort to improve quality at every level of the organisation.
QbD (Quality by Design) - quality cannot be put into a product by testing, it has to be designed into the product from the start.

6σ (six sigma) - a system for the evaluation of processes to ensure that 99.9999998% of all products meet the specification, by reducing waste and improving yield.
Lean manufacturing and lean sigma are similar to 6σ, but use slightly varying terminology and processes

Question 15

What organisations are involved in QA?

Answer 15

MHRA - Medicines & Healthcare Products Regulatory Agency.

EMA – European Medicines Agency (based in Amsterdam)

FDA – Food & Drug Administration

PMDA & MHLW – Pharmaceuticals & Medical Devices Agency, Japan & Ministry of Health, Labour & Welfare

ICH – International Conference on the Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use

WHO – World Health Organisation

Question 16

1. How would you define quality?

Answer 16

1. Quality in the manufacture of medicines refers to the extent to which a pharmaceutical product consistently meets the intended specifications and requirements for its identity, strength, purity, and potency. This encompasses all aspects of the manufacturing process, including the sourcing of raw materials, development of the formulation, manufacturing process design, and packaging and labeling.
   To ensure quality in the manufacture of medicines, pharmaceutical companies must adhere to strict regulations and guidelines established by regulatory agencies such as the FDA (U.S. Food and Drug Administration) and the EMA (European Medicines Agency). These guidelines outline the standards for good manufacturing practices (GMPs) that companies must follow to ensure the quality and safety of their products.
   Quality in the manufacture of medicines also involves rigorous testing and quality control measures throughout the manufacturing process, including testing of raw materials and finished products, in-process controls, and batch release testing. This helps to ensure that each batch of product meets the required quality standards before it is released to the market.
   Overall, ensuring quality in the manufacture of medicines is essential to ensure patient safety and to maintain public confidence in the pharmaceutical industry.

Question 17

2. What is Quality Assurance (QA) and why would it be needed?

Question 18

3. What is a medicinal product or medicine?

Answer 18

3) A medicinal product is any product that is intended to be used to prevent, treat, or cure a disease or medical condition, or to modify a physiological function in the body. Medicinal products can be made from a variety of substances, including chemicals, biological substances, or a combination of both.
Medicinal products can be classified into two main categories: over-the-counter (OTC) and prescription-only medicines (POMs). OTC medicines are those that can be purchased without a prescription from a healthcare professional, and are typically used to treat common health conditions like pain, fever, and colds. POMs, on the other hand, are medicines that can only be prescribed by a qualified healthcare professional, and are often used to treat more serious medical conditions like cancer, heart disease, and mental illness.
Medicinal products are subject to strict regulation in many countries around the world to ensure their safety, quality, and effectiveness. Regulatory agencies like the FDA (U.S. Food and Drug Administration) and the EMA (European Medicines Agency) evaluate medicinal products through a rigorous approval process, which involves testing and evaluation of the product’s safety and efficacy, as well as the manufacturing and quality control processes used to produce it.

Question 19

4. Define the following terms in relation to medicinal products:
   a. Batch.
   b. Batch Record (either manufacturing or packaging).
   c. Batch Number and state its purpose.
   d. Master batch document.
   e. Master formula.
   f. Master packaging documents.
   g. Specifications.
   h. Standard Operating Procedures (SOPs)

Answer 19

4) In the context of manufacturing and quality control of products, a batch refers to a specific quantity of a product that is produced at one time using the same manufacturing process and raw materials.
For example, in the pharmaceutical industry, a batch of a medicinal product may consist of a certain number of finished dosage forms (e.g., tablets, capsules, injections) that are produced using the same raw materials, manufacturing process, and equipment.
Each batch of a product is assigned a unique identification number or code, which allows for traceability and accountability throughout the manufacturing and distribution process.

5) A batch record is a detailed document that provides a complete history of a specific batch of a product, including all the steps involved in its manufacture, testing, and release. It serves as a primary source of information about the production process for that batch, and is an important part of the documentation required for regulatory compliance.
The batch record typically includes information such as the batch number, production date, expiration date, and the identity and quantity of all raw materials used in the manufacturing process. It also includes a detailed record of all the manufacturing steps, such as mixing, blending, filling, labeling, and packaging.
In addition, the batch record includes information about any testing and quality control measures that were performed during the production process, as well as the results of those tests. This includes information about the equipment used, the personnel involved, and any deviations or changes that were made to the production process.
The batch record is an important part of the documentation required for regulatory compliance, as it serves as a permanent record of the production process and can be used to verify that the product was manufactured in compliance with the established quality standards. It is also used to facilitate traceability, as it provides a detailed history of the production process for each batch of a product.



6) A master batch record is a controlled document that provides a comprehensive overview of the manufacturing process for a particular product or group of products. It serves as a template or blueprint for the production of multiple batches of the same product, and includes all the necessary information and instructions for the production process.

7) A master formula is a document that provides a detailed recipe or formula for the production of a specific product. It includes all the necessary information about the ingredients, quantities, and procedures required to produce the product, as well as any special instructions or precautions that are necessary to ensure product quality and consistency. 
In the pharmaceutical industry, the master formula is an essential part of the manufacturing process for medicinal products, as it provides the necessary information for the production of the product, including details on the active ingredients, excipients, and any other components required for the formulation.

8) Master packaging documents are controlled documents that provide a comprehensive overview of the packaging process for a particular product or group of products. They contain detailed information and instructions for the packaging process, including the types of packaging materials and equipment to be used, as well as any special handling or storage requirements.
The master packaging document typically includes information such as the packaging specifications, labeling requirements, and any regulatory or quality control requirements. It may also include information about the printing and design of packaging materials, as well as instructions for assembling and filling packaging components.



9) In medicine design, specifications refer to the detailed requirements and standards that a medicinal product must meet in order to be considered safe, effective, and of high quality.
These specifications are typically defined during the product development phase and are used as a basis for the design and manufacture of the product. They may include information such as the chemical composition and physical properties of the product, as well as its intended use, dosage form, strength, and packaging.
The specifications for a medicinal product are important because they help to ensure that the product is consistent and reliable from batch to batch, and that it meets the necessary standards for safety and effectiveness. They are also a key part of the documentation required for regulatory compliance, as they provide evidence that the product has been designed and manufactured in accordance with the established quality standards.
The specifications for a medicinal product may be established by the regulatory agency responsible for approving the product for sale, or by the manufacturer in accordance with regulatory requirements. They are subject to periodic review and may be revised as necessary to ensure that the product continues to meet the necessary quality standards.



10) SOPs, or Standard Operating Procedures, are written documents that outline the step-by-step procedures and instructions for completing a specific task or process in a consistent and standardized manner.
SOPs are used in a wide range of industries, including pharmaceuticals, manufacturing, and healthcare, to ensure that processes are performed in a safe, efficient, and consistent manner. They provide a clear and concise guide for employees to follow, which helps to reduce errors, improve efficiency, and maintain quality standards.

Question 20

5. What are the GxPs (GMP, GLP & GCP) and to what areas of medicinal development do they apply?

Answer 20

11) GxP is a general term used to refer to a set of regulations and guidelines that govern the quality and safety of products in various industries, including pharmaceuticals, medical devices, and food products. The “x” in GxP can be replaced with different letters to indicate the specific area of regulation, such as GMP (Good Manufacturing Practices), GLP (Good Laboratory Practices), and GCP (Good Clinical Practices).

Question 21

8. Who monitors medicines (within the UK)?

Answer 21

1) In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency responsible for regulating and monitoring medicinal products.
The MHRA is responsible for ensuring that all medicines and medical devices marketed in the UK are safe, effective, and of high quality. This includes regulating the manufacture, distribution, and advertising of medicinal products, as well as monitoring their safety and efficacy through post-marketing surveillance and pharmacovigilance activities.
The MHRA also works closely with other regulatory agencies, both within the UK and internationally, to ensure that medicines and medical devices meet the necessary regulatory standards and are safe for use by patients and consumers.
Overall, the MHRA plays a critical role in ensuring the safety and efficacy of medicinal products in the UK, and works to promote public health by maintaining high standards of quality and safety in the pharmaceutical industry.

Question 22

6. What is Quality Control (QC)?

Question 23

7. How are QA, GMP and QC related?

Question 24

9. What is the ICH and what is its purpose?

Question 25

10. What is the purpose of a QP within a pharmaceutical organisation.