1. ERT 421 Good Manufacturing Practice for Bioprocess Engineering Test 1: answer scheme

2. Briefly describe the six common general GMP requirements. 1.The establishment and maintenance of an effective quality assurance system; [4 marks] 2.Control of the process; [4 marks] 3.Personnel that are suitably qualified, trained and supervised; [4 marks] 4.Premises and equipment that have been located, designed, installed, operated and maintained to suit intended operations; [4 marks] 5.Maintenance of adequate records of all aspects of the process so that in the event of a problem being identified, an investigation can trace the complete history of the process, including how, when, and where it was produced, under what conditions and by whom (i.e. an audit trail); [5 marks] 6.The prevention of contamination from any source, in particular from components, environment, premises and equipment by the use of suitable premises and equipment and through standard operating procedures. [5 marks]

3. List the contents of Validation Master Plan (VMP). (1) approval page; [2 marks] (2) introduction; [2 marks] (3) the aim; [2 marks] (4) descriptions of: –facility; [2 marks] –services/utilities; [2 marks] –equipment; [2 marks] –products; [2 marks] –computer systems; [2 marks] (5) validation approach: [2 marks] –overall; [2 marks] –detail (matrix of validation documents); [2 marks] (6) other documentation. [2 marks]

4. Explain the purpose of design qualification (DQ) The purpose of design qualification is to ensure that the final design: accords with all relevant specifications and design intentions; [5 marks] meets the requirements of the process, product and user; [5 marks] adequately specifies all necessary supporting documentation; [5 marks] complies with the requirements and principles of GMP. [5 marks]

5. Define process validation (PV). Process validation is defined as: ‘Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes’ [10 marks]

6. Explain why cleaning validation is essential in any pharmaceutical production process. to ensure that the appropriate level of general cleanliness is maintained in order to prevent the accumulation of dirt and microbial contamination which could affect the quality of the product; [10 marks] to minimize the risk of cross-contamination from one active product into the subsequent product, which could lead to serious adverse effects on patients. Cross- contamination could also result in degradation of the main product and loss of potency. [10 marks]