Reference standards refer to international or national standards.
A specification is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria which are numerical limits, ranges, or other criteria for the tests described. It establishes the set of criteria to which a drug substance, drug product or materials at other stages of its manufacture should conform to be considered acceptable for its intended use. "Conformance to specification" means that the drug substance and drug product, when tested according to the listed analytical procedures, will meet the acceptance criteria. Specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities as conditions of approval. Reference: EMEA's guidelines
FAO (Food and Agriculture Organization of the United Nations). Official website: link
WHO (World Health Organization). Official website: link
Biological activity is the specific ability or capacity of the product to achieve a defined biological effect. Potency is the quantitative measure of the biological activity. Reference: EMEA's guidelines (link).
Impurity is any component present in the drug substance or drug product which is not the desired product, a product-related substance, or excipient including buffer components. It may be either process- or product-related. Reference: EMEA's guidelines (link).
Contaminants are any adventitiously introduced materials (e.g., chemical, biochemical, or microbial species) not intended to be part of the manufacturing process of the drug substance or drug product. Reference: EMEA's guidelines (link).
Acceptance criteria are numerical limits, ranges, or other suitable measures for acceptance of the results of analytical procedures which the drug substance or drug product or materials at other stages of their manufacture should meet. Reference: EMEA's guidelines (link).
A Wikipedia article on biopharmaceuticals: link.
An in-house primary reference material is an appropriately characterized material prepared by the manufacturer from a representative lot(s) for the purpose of biological assay and physicochemical testing of subsequent lots, and against which in-house working reference material is calibrated.
In contrast, an in-house working reference material is a material prepared similarly to the primary reference material that is established solely to assess and control subsequent lots for the individual attribute in question. It is always calibrated against the in-house primary reference material. Reference: EMEA's guidelines (link).
A drug substance is the material which is subsequently formulated with excipients to produce the drug product. It can be composed of the desired product, product-related substances, and product- and process-related impurities. It may also contain excipients including other components such as buffers. Reference: EMEA's guidelines (link).
Potency is the measure of the biological activity using a suitably quantitative biological assay (also called potency assay or bioassay), based on the attribute of the product which is linked to the relevant biological properties. Reference: EMEA's guidelines (link).
A desired product is (1) the protein which has the expected structure, or (2) the protein which is expected from the DNA sequence and anticipated post-translational modification (including glycoforms), and from the intended downstream modification to produce an active biological molecule. Reference: EMEA's guidelines (link).
An action limit is an internal (in-house) value used to assess the consistency of the process at less critical steps. Reference: EMEA's guidelines (link).
A drug product is a pharmaceutical product type that contains a drug substance, generally, in association with excipients. Reference: EMEA's guidelines (link).
An excipient is an ingredient added intentionally to the drug substance which should not have pharmacological properties in the quantity used. Reference: EMEA's guidelines (link).
Degradation products are molecular variants resulting from changes in the desired product or product-related substances brought about over time and/or by the action of, e.g., light, temperature, pH, water, or by reaction with an excipient and/or the immediate container/closure system. Such changes may occur as a result of manufacture and/or storage (e.g., deamidation, oxidation, aggregation, proteolysis). Degradation products may be either product-related substances, or product-related impurities. Reference: EMEA's guidelines (link).
Product-related substances are molecular variants of the desired product formed during manufacture and/or storage which are active and have no deleterious effect on the safety and efficacy of the drug product. These variants possess properties comparable to the desired product and are not considered impurities. Reference: EMEA's guidelines (link).
Product-related impurities are molecular variants of the desired product (e.g., precursors, certain degradation products arising during manufacture and/or storage) which do not have properties comparable to those of the desired product with respect to activity, efficacy, and safety. Reference: EMEA's guidelines (link).
Process-related substances are impurities that are derived from the manufacturing process. They may be derived from cell substrates (e.g., host cell proteins, host cell DNA), cell culture (e.g., inducers, antibiotics, or media components), or downstream processing (e.g., processing reagents or column leachables). Reference: EMEA's guidelines (link).
- EMEA. TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS (CPMP/ICH/365/96). [Online] September 1999. (link).
- FAO/WHO. Codex Alimentarius. [Online] 2020. [Cited: Mar 03, 2020.] (link).
- Biotechnology. Codex Alimentarius. [Online] 2020. [Cited: Mar 03, 2020.] (link).
- Välimaa, Anna-Liisa, et al., et al. Fish and fish side streams are valuable sources of high-value components. Food Quality and Safety. December 2019, Vol. 3, 4, pp. 209-226.
- Erondu, E S and Anyanwu, P E. Potential hazards and risks associated with the aquaculture industry. African Journal of Biotechnology. 2005, Vol. 4, 13, pp. 1622-1627.
- Codex Alimentarius Commission, CAC. Guideline for the validation of food safety control measures, CAC/GL 69. Rome : Fao, 2008.
- Codex Alimentarius Commision, CAC. Guidelines on performance criteria and validation of methods for detection, identification and quantification of specific DNA sequences and specific proteins in foods, CAC/GL 74-2010. Rome : FAO, 2010.
- International Union of Pure and Applied Chemistry, IUPAC. Harmonized Guidelines for Internal Quality Control in Analytical Chemistry Laboratories. Pure & Appl. Chem. 1995, Vol. 67, 649-666.