Written exam for the post of medical cosmetics registration officer and Public Health laboratory registration officer questions and answers.

Question 1. All medicated cosmetic products to be manufactured, supplied, distributed or sold in Rwanda market should prior be registered by the Rwanda FDA. This is in accordance with provisions of the Rwanda food and drug authority regulations.

a.       Why do you think is mandatory to be registered by the authority? (5marks)

b.      Depending on the nature and characteristics of the cosmetic, the critical parameters (main parameters in cosmetics) may be analyzed for raw materials and /or finished products before registration, give us 5 of them(10marks)

a)      Registration is mandatory because:

·         Product registration enables public health protection form harmful contamination associated with the product.

·         It helps in formulation of regulations and policy

·         It helps in industrial economic growth

·         It facilitates in product traceability

·         The data given during registration used during the assessment of the safety, efficacy of product to its intended uses

b)     Critical parameters of cosmetic

·         Moisture content

·         Ash content

·         Alcohol content especially for hand sanitizer

·         pH value

·         Chlorine content for Disinfectant

·         Heavy metals

·         Microbiological parameters like Staphylococcus aureus

·         Hydroquinone content

·         Total fatty acid

Question 2. Quality management system and Good manufacturing practice are required in pharmaceutical production as well as in manufacturing of pesticides and chemicals (10 marks)

a)      What are the components of quality management system?

b)      What is the GMP and its aim while inspecting a manufacturing facility?

a.      Components of quality management system:

·         Management review including personnel, equipment, facilities and environment management

·         Internal Audit

·         Record

·         Documentation including quality manual, SOPs, Guidelines and so on

·         Improvement such as Corrective action and Preventive actions

·         Risks and opportunities

b.      GMP is that part of quality management which ensures that products are consistently produced and controlled according to the quality standards appropriate to their intended use and as required by the marketing authorization, clinical trial authorization or product specification. GMP is aimed primarily at managing and minimizing the risks inherent in pharmaceutical manufacture to ensure the quality, safety and efficacy of product.

Question 3. During the manufacturing process of an API, impurities may affect the process. List at least four (4) potential impurities that can be found in an API or that can be potentially carried over into the final API (10 marks)

 Potential impurities that can be founded in an API are

·         API side product residual

·         Catalyst residual like Pt and lead

·         Raw material residual

·         Residual solvents

·         Degradation products

·         Inorganic impurities including heavy metals like Arsenic

·         Reaction by products 

·         Enantiomeric impurities

·         Impurities in the starting materials

·         Excipient and API interactions

·         Container and API interactions

·         Genotoxic impurities 

Question 4. What are the accelerated and long term stability study conditions for finished pharmaceutical product as specified in Rwanda FDA guidelines (5 marks)

During stability studies of Finished Pharmaceutical Product, the product should be subjected on a given temperature and humidity with respect to the relevant climatic zone. Therefore, by considering our country in its climatic zone, the accelerated stability study conditions are 40o C ± 2o C/ 75% RH ± 5% RH within study period of 6months while long terms stability study conditions are 30o C ± 2o C/ 65% RH ± 5% RH or 25o C ± 2o C/ 60% RH ± 5% RH within proposed shelf life.

 Question 5. Medicated cosmetics can be available in different forms, write five (5) of them (10 marks)

Medicate cosmetics are products that have both cosmetic and therapeutic effect and are intended to have beneficial effect on skin health and body. These products can be founded in the following forms: 

·         Creams/ Emulsions

·         Body lotions

·         Powders

·         Aerosol

·         Solutions

·         Ointments / Pastes

·         Suspensions

·         Gels

·         Sticks

·         Capsules

·         Tablets

·         Spray

·         Granules

·         Pencils