Drug product definition

In order to illustrate an example of process design for the manufacture of enantiopure drug substances on an industrial SMB system, consider manufacturing 10 ton/ year of an enantiopure drug. The racemic drug by definition is a 50 50 mixture of each enantiomer (products A and B). The goal is to process enantiopure drug substances in order to obtain 99 % purity for both the extract and the raffinate. 

The sampling kit consists of the labelled urea, which is a drug a sampling straw, which is a device and a sample container, which would be considered an in-vitro diagnostic (IVD) medical device under EU definitions. Other examples of diagnostic drug products used in conjunction with medical devices include dyes administered to visualise blocked veins and arteries. 

Excipients also meet the definition of component in the Good Manufacturing Practice (GMP) regulations in 21 CFR Section 210.3(b)(3) Component means any ingredient intended for use in the manufacture of a drug product, including those that may not appear in such drug product. ... 

Are drug products with different strengths regarded as proportionally similar in their active and inactive ingredients compared to the product on which an appropiate in vivo (BA/ BE) study has been performed (with respect to one of following three definitions) ... 

General provisions contain recommendations that are considered the minimum current good compounding practices for the preparation of drug products by state-licensed pharmacies for dispensing or administration to humans or animals. The document contains definitions of compounding and manufacturing. 

Dry heat is used to sterihze and depyrogenate components and drug products. The definition of dry heat sterilization is 170 °C for at least 2 hours and a depyrogenation cycle at 250 °C for more than 30 minutes. Typical equipment includes tunnel sterilizers (force convection, infrared, fiame) and microwave sterilizers. An important aspect is the need to ensure air supply is filtered through HEPA filters. Biological indicators such as Bacillus subtilis can be used to gauge the performance of sterilization. 

From the foregoing discussion, there are clearly many issues to be confronted when scaling up the pan-coating process. Evidently, the more definitive data that are developed initially, the less likely that major problems will occur later on, especially problems that could inevitably delay a product launch and cost much in the way of lost revenues, particularly when dealing with a potentially blockbuster drug product. 

These requirements will not be enforced for over-the-counter (OTC) drug products if the products and all their ingredients are ordinarily marketed and considered as human foods and which products may also fall within the legal definition of drugs by virtue of their intended use. 

Definition of the desirable attributes of the drug product or components thereof as well as those characteristics that are not desired... 

The computer system URS needs to describe the levels of functionality and operability required from the computer system, its application, and the location with regard to the process. Definition of approved and accurate manufacturing and process data is a key objective of the URS and is essential in order for the computer system supplier or integrator to fully understand and develop the computer application and to engineer the field instrumentation and electrical controls. This must include the quality-related critical parameters that are fundamental in determining and ensuring the satisfactory quality of a drug product. Parameters, data, and functions that are necessary to uphold GMP must always be considered as firm requirements and candidates for validation. 

The fact that many products (e.g., liquids, sprays, powders, gels, some drug products, and cosmetics) cannot exist or be transported without a pack, however, means that for these types of products a broader definition is needed to cover the functions of the pack and the packaging operation. 

The ICH definition of stress testing for the drug product is shown below (7) ... 

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