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level: Level 1

Questions and Answers List

level questions: Level 1

Question	Answer
The aim of this is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. Information from its studies can be a basis for quality risk management.	pharmaceutical development
Quality should be built in by design. TRUE OR FALSE	TRUE
should describe the knowledge that establishes that the type of dosage form selected and the formulation proposed are suitable for the intended use. It includes sufficient information in each part to provide an understanding of the development of the drug product and its manufacturing process. ASPECTS like drug substances, excipients, container closure systems, and manufacturing processes that are critical to product quality should be determined and control strategies justified.	Pharmaceutical Development section
the applicant can choose to conduct __ that can lead to an enhanced knowledge of product performance over a wider range of material attributes, processing options and process parameters.	Pharmaceutical Development Studies
physicochemical and biological properties of the __ that can influence the performance of the drug product and its manufacturability, or were specifically designed into the drug substance (e.g., solid state properties), should be identified and discussed.	drug substance
The compatibility of the drug substance with __ listed in 3.2.P.1 should be evaluated. For products that contain more than one drug substance, the compatibility of the drug substances with each other should also be evaluated.	Excipients
The __ chosen, their concentration, and the characteristics that can influence the drug product performance (e.g., stability, bioavailability) or manufacturability should be discussed relative to the respective function of each.	Excipients
A SUMMARY should be provided describing the development of the formulation, including identification of those attributes that are critical to the quality of the drug. The summary should take into consideration:	1 Intended usage and route of administration. 2 Choice of drug product components 3 The manufacturing process 4 Knowledge gained from the development of similar drug product(s).
A summary of __ used in clinical safety and efficacy and in any relevant bioavailability or bioequivalence studies should be provided. Any changes between the proposed commercial __ and those __ used in pivotal clinical batches and primary stability batches should be clearly described and the rationale for the changes provided.	formulations
Any __ features of the drug product (e.g., tablet score line, overfill, anti-counterfeiting measure as it affects the drug product) should be identified and a rationale provided for their use.	special design
Use of it in a drug substance is to compensate for degradation during manufacture or a product’s shelf life, or to extend shelf life, is discouraged. Any __ in the manufacture of the drug product, whether they appear in the final formulated product or not, should be JUSTIFIED considering the safety and efficacy of the product.	OVERAGES
The __ relevant to the safety, performance or manufacturability of the drug product should be identified and discussed. This includes the physiological implications of drug substance and formulation attributes.	physicochemical and biological properties
For those products intended to be sterile, an appropriate method of sterilization for the __ and __ should be chosen and the choice justified.	drug product, primary packaging material
IN Manufacturing Process Development, Information should be presented in a way that facilitates comparison of the processes and the corresponding batch analyses information (3.2.P.5.4). The information should include, for example,	1 The identity and use of the batches produced 2 The manufacturing site 3 The batch size 4 Any significant equipment differences
Ability of a PROCESS to tolerate variability of materials and changes of the process and equipment without negative impact on quality An understanding of this can be useful in risk assessment and risk reduction and to support future manufacturing and process improvement, especially in conjunction with the use of risk management tools	Process Robustness
IN Container Closure System, Consideration should be given to the intended use of the drug product and the suitability of the container closure system for storage and transportation (shipping), including the __ for bulk drug product, where appropriate	storage and shipping container
The choice of materials for __ should be justified. The discussion should describe studies performed to demonstrate the integrity of the container and closure. A possible interaction between __ or label should be considered.	primary packaging, product and container
The microbiological attributes of the drug product should be discussed. The discussion should include:	1 The rationale for performing or not performing microbial limits testing for non sterile drug products 2 The selection and effectiveness of preservative systems in products containing antimicrobial preservative or the antimicrobial effectiveness of products that are inherently antimicrobial; 3 For sterile products, the integrity of the container closure system as it relates to preventing microbial contamination.
Although chemical testing for preservative content is the attribute normally included in the drug product specification, __ effectiveness should be demonstrated during development.	Antimicrobial Preservative
May demonstrate a lowest specified concentration of antimicrobial preservative to be effective in controlling micro organisms.	Antimicrobial Preservative Effectiveness Test
The compatibility of the drug product with reconstitution diluents should be addressed to provide appropriate and supportive information for the labelling. This information should cover:	1 the recommended in-use shelf life - recommended storage temperature - extremes of concentration. 2 admixture or dilution of products prior to administration