Quality Assurance and Regulatory Affairs Flashcards
- Briefly describe the purpose of a Qualified Person (QP) within the context of an organisation which manufactures and markets medicines. What are the roles of a QP?
In the manufacture of medicines, a Qualified Person (QP) is a person who has been authorized to release medicinal products for sale or supply. The QP is responsible for ensuring that medicinal products are manufactured and tested in accordance with Good Manufacturing Practice (GMP) and meet the requirements of the marketing authorization. In the European Union, the role of the QP is defined in Directive 2001/83/EC and the European Medicines Agency (EMA) guidelines.
The QP is required to have a sound knowledge of the manufacturing process, quality control, and quality assurance of medicinal products, as well as a thorough understanding of regulatory requirements. The QP is responsible for ensuring that the product has been manufactured in accordance with the marketing authorization and that all necessary tests and checks have been performed.
The QP is also responsible for the release of batches of medicinal products for sale or supply, which involves reviewing the batch documentation, including the production and quality control records, and making a decision on whether the batch can be released for sale or supply.
The QP is a critical role in the manufacture of medicines as they provide an independent assessment of the quality of the product and ensure that it meets the required standards for safety, efficacy, and quality. They play a crucial role in ensuring that only safe and effective medicines are released to the market, and they are held accountable for any quality issues that may arise.
As the term ‘Qualified Person’ is defined in law identify the four bodies who can certify whether a person is appropriately trained to hold such a title.
- The Royal Pharmaceutical Society: The Royal Pharmaceutical Society (RPS) is the professional body for pharmacists in England, Scotland, and Wales. They offer a QP qualification program that is accredited by the United Kingdom Accreditation Service (UKAS).
- The Irish Institute of Pharmacy: The Irish Institute of Pharmacy (IIOP) is the professional body for pharmacists in Ireland. They offer a QP qualification program that is recognized by the European Union.
- The Pharmaceutical Society of Northern Ireland: The Pharmaceutical Society of Northern Ireland (PSNI) is the regulatory body for pharmacists in Northern Ireland. They offer a QP qualification program that is recognized by the European Union.
- The Medicines and Healthcare products Regulatory Agency: The Medicines and Healthcare products Regulatory Agency (MHRA) is the regulatory body for medicines and medical devices in the United Kingdom. They are responsible for approving QPs and can also provide guidance on the qualifications and training required to become a QP.
Outline some of the other departments on which the QP would rely to ensure all processes and procedures were carried out as required before they could approve a batch of product.
Quality Control (QC): The QC department is responsible for testing the raw materials, intermediates, and finished products to ensure that they meet the specifications outlined in the marketing authorization. The QP relies on the QC department to perform the required tests and to provide accurate and reliable data on the quality of the product.
Production: The production department is responsible for manufacturing the medicinal product according to the approved process and batch records. The QP relies on the production department to follow the approved procedures and to document all critical steps in the manufacturing process.
Quality Assurance (QA): The QA department is responsible for ensuring that all procedures and processes are carried out in accordance with GMP and the marketing authorization. The QP relies on the QA department to review and approve all documents, including batch records, procedures, and specifications, and to identify any deviations or issues that may impact the quality of the product.
Engineering: The engineering department is responsible for maintaining and calibrating the manufacturing equipment and facilities. The QP relies on the engineering department to ensure that the equipment is functioning properly and that any deviations or issues are addressed before they impact the quality of the product.
Regulatory Affairs: The regulatory affairs department is responsible for ensuring that the medicinal product meets the requirements of the marketing authorization and any applicable regulatory guidelines. The QP relies on the regulatory affairs department to provide accurate and up-to-date information on the regulatory requirements and to ensure that any changes to the manufacturing process or product formulation are approved by the relevant regulatory authorities.
- Outline what would happen in the event that a QP was suspected or found to have approved a product for sale or supply without having conducted all of the appropriate checks.
Investigation: The pharmaceutical manufacturing company would conduct an investigation into the circumstances surrounding the incident. This may involve reviewing batch records, testing data, and any other relevant documents to determine what happened and how it could have been prevented.
Reporting: The company may be required to report the incident to the relevant regulatory authorities, such as the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK or the European Medicines Agency (EMA) in the EU. The regulatory authorities would then conduct their own investigation and may take further action if necessary.
Corrective action: The company would be required to take corrective action to prevent similar incidents from occurring in the future. This may involve reviewing and updating procedures, providing additional training to staff, or implementing new quality control measures.
Disciplinary action: The QP may face disciplinary action from their employer, which could include suspension or termination of employment. They may also face regulatory action, such as a suspension or revocation of their QP status, which would prevent them from carrying out the role in the future.
Legal action: In some cases, the QP may face legal action if their actions have resulted in harm to patients or if they have breached any relevant laws or regulations.
- Briefly explain when each of the following types of marketing authorisation application procedures would be used:
a. Centralised procedure.
b. National procedure.
c. Mutual recognition procedure.
d. Decentralised procedure.
. Centralized Procedure: This procedure is used for the authorization of certain types of medicinal products such as biotech products, advanced therapies, and orphan medicinal products. It involves the submission of a single application to the European Medicines Agency (EMA) and results in a single marketing authorization that is valid in all EU Member States.
b. National Procedure: This procedure is used for the authorization of medicinal products that are intended for use in a single EU Member State. The application is submitted to the national regulatory authority of the Member State where the product will be marketed.
c. Mutual Recognition Procedure: This procedure is used for the authorization of medicinal products that have already been authorized in one EU Member State and are intended for use in another Member State. The company submits an application to the regulatory authority of the Member State where the product is already authorized. If the regulatory authority agrees that the product meets the necessary requirements, a marketing authorization is granted in that Member State. The other Member States then have to recognize the marketing authorization and can only raise objections if there are serious concerns about the safety or efficacy of the product.
d. Decentralized Procedure: This procedure is used for the authorization of medicinal products that are intended for use in several EU Member States, but for which there is no existing marketing authorization in any EU Member State. The company submits an application to one Member State, which is considered the Reference Member State (RMS). The RMS then prepares a draft assessment report and sends it to the other Member States, which are known as Concerned Member States (CMS). The CMS then have to agree or disagree with the RMS’s assessment within a certain timeframe. If there are no objections, the RMS issues a marketing authorization that is valid in all Member States where the product is intended to be marketed.
- Explain what the following licence types allows the holder to do:
a. Manufacture / importer licence.
b. Manufacturer ‘specials’ licence.
c. Manufacturer licence for investigational medicinal products.
d. Manufacturer licence exempt advanced therapy products (Hospital exemption licence).
e. Manufacturer licence for non-orthodox practitioners.
a. Manufacture / Importer License: This license allows the holder to manufacture or import medicinal products in a country. It is issued by the regulatory authority of the country and is necessary for any company or individual that wants to engage in the manufacture or importation of medicinal products.
b. Manufacturer ‘Specials’ License: This license allows the holder to manufacture unlicensed medicinal products, known as “specials”, in response to a specific request from a healthcare professional or a patient. These products are not authorized by the regulatory authority and are manufactured on a case-by-case basis to meet specific patient needs.
c. Manufacturer License for Investigational Medicinal Products: This license allows the holder to manufacture and supply investigational medicinal products (IMPs) for use in clinical trials. IMPs are medicinal products that are being tested in clinical trials and have not yet been authorized for marketing.
d. Manufacturer License Exempt Advanced Therapy Products (Hospital Exemption License): This license allows the holder, usually a hospital or healthcare institution, to manufacture and supply advanced therapy medicinal products (ATMPs) for use in individual patients under specific conditions. These products are exempt from the normal marketing authorization requirements but must meet certain quality and safety standards.
e. Manufacturer License for Non-Orthodox Practitioners: This license allows the holder, who may be a traditional healer or a practitioner of alternative medicine, to manufacture and supply medicinal products that are used in their practice. These products may be based on traditional remedies or alternative therapies and may not be authorized by the regulatory authority. However, they must meet certain quality and safety standards and must not make false or misleading claims about their efficacy.
- Explain the flowing abbreviations used within the development and production of medicinal products and state to what aspects of the process they apply:
a. GMP.
b. GLP.
c. GCP.
d. GPvP.
e. GDP.
a. GMP: Good Manufacturing Practice. It is a set of guidelines that ensures the quality and safety of medicinal products during their manufacturing, packaging, labeling, and storage.
b. GLP: Good Laboratory Practice. It is a set of guidelines that ensures the quality and integrity of non-clinical laboratory studies conducted for the development of medicinal products.
c. GCP: Good Clinical Practice. It is a set of guidelines that ensures the ethical and scientific standards of clinical trials conducted on human subjects for the development of medicinal products.
d. GPvP: Good Pharmacovigilance Practice. It is a set of guidelines that ensures the safety of medicinal products after they have been authorized for marketing by monitoring and reporting adverse reactions to the regulatory authority.
e. GDP: Good Distribution Practice. It is a set of guidelines that ensures the quality and integrity of medicinal products during their distribution from the manufacturer to the point of use. It covers aspects such as storage, transportation, and documentation.
Explain the role of the Regulatory Affairs department in the approval of licences of the sale or supply of medicines
The Regulatory Affairs department plays a crucial role in the approval of licenses for the sale or supply of medicines. This department is responsible for ensuring that pharmaceutical products meet the regulatory requirements of the country or region in which they are intended to be marketed.
The department works closely with other departments within the pharmaceutical company, such as R&D, quality control, and manufacturing, to prepare and submit regulatory applications for marketing authorization. They compile and submit the necessary documentation and data to regulatory authorities, such as the FDA in the United States or the EMA in Europe, to obtain the necessary approvals.
The Regulatory Affairs department also monitors changes in regulations and guidelines related to the development and marketing of pharmaceutical products, and communicates these changes to relevant departments within the company to ensure compliance. They may also communicate with regulatory authorities on behalf of the company regarding product development, manufacturing, and marketing.
Overall, the Regulatory Affairs department is responsible for ensuring that pharmaceutical products meet the necessary regulatory requirements for marketing authorization, and that the company remains in compliance with regulatory guidelines and standards throughout the product life cycle.
Explain the various types of licences which are available allowing the manufacture, distribution, importation, sale and supply of medicines.
There are various types of licenses available for the manufacture, distribution, importation, sale, and supply of medicines. Some of the commonly used licenses in the pharmaceutical industry are:
Manufacturer’s license: This license is required for any person or organization that intends to manufacture medicinal products. It ensures that the manufacturer is capable of producing quality medicines in compliance with the regulatory guidelines.
Importer’s license: This license is required for any person or organization that intends to import medicinal products into a country. It ensures that the importer is authorized to bring in medicinal products from another country and is in compliance with the regulatory requirements.
Wholesale dealer’s license: This license is required for any person or organization that intends to distribute medicinal products to other wholesalers, retailers, or hospitals. It ensures that the wholesale dealer is authorized to distribute medicinal products and is in compliance with the regulatory requirements.
Retail pharmacy license: This license is required for any person or organization that intends to sell medicinal products to the public. It ensures that the pharmacy is authorized to sell medicinal products and is in compliance with the regulatory requirements.
Specials manufacturer’s license: This license is required for any person or organization that intends to manufacture medicinal products that are not authorized or available on the market. It ensures that the manufacturer is capable of producing these products in compliance with the regulatory guidelines.
Investigational medicinal products license: This license is required for any person or organization that intends to manufacture or import investigational medicinal products for use in clinical trials. It ensures that the products are manufactured in compliance with the regulatory guidelines and are safe for use in clinical trials.
Overall, the different types of licenses available ensure that medicinal products are manufactured, distributed, imported, sold, and supplied in compliance with the regulatory requirements and are safe for use by the public.
What GxPs which apply to the development, preparation and distribution of medicines
Good Laboratory Practice (GLP): This standard ensures that non-clinical safety studies are planned, conducted, reported, and documented in compliance with the regulatory requirements.
Good Clinical Practice (GCP): This standard ensures that clinical trials are designed, conducted, recorded, and reported in compliance with the regulatory requirements to ensure that the safety, efficacy, and quality of the medicine are maintained.
Good Manufacturing Practice (GMP): This standard ensures that medicinal products are manufactured and controlled in compliance with the regulatory requirements to ensure their safety, quality, and efficacy.
Good Distribution Practice (GDP): This standard ensures that medicinal products are distributed and stored in compliance with the regulatory requirements to ensure their safety, quality, and efficacy.
Good Pharmacovigilance Practice (GPvP): This standard ensures that the safety of medicinal products is monitored and reported in compliance with the regulatory requirements.
Good Automated Manufacturing Practice (GAMP): This standard provides guidelines for the validation and control of automated systems used in the manufacture, testing, and distribution of medicinal products.
