But now a broad team of expertise is needed, due to increased access to unique and complex materials, global sourcing, handling methods, customer locations, and regulations.The team assesses if the material has limitations or may be too costly to handle, and determines if additional measures are necessary to prevent potential safety issues for the employees and product.As such, they must meet regulatory requirements (safe and legal for your intended use) and your specifications (contribute to the functionality and quality of your process and product).Historically, research and development worked alone when selecting a new raw material. Physical, chemical, or other means that can be used to control an identified food safety hazard. An instrument or device used to indicate conditions during processing at a critical control point. The individual with overall authority on-site or a higher level official of the establishment. (1) Every official establishment shall conduct, or have conducted for it, a hazard analysis to determine the food safety hazards reasonably likely to occur in the production process and identify the preventive measures the establishment can apply to control those hazards. (ix) Product with secondary inhibitors - not shelf stable.(3) Food safety hazards might be expected to arise from the following: (i) Natural toxins; (ii) Microbiological contamination; (iii) Chemical contamination; (iv) Pesticides; (v) Drug residues; (vi) Zoonotic diseases; (vii) Decomposition; (viii) Parasites; (ix) Unapproved use of direct or indirect food or color additives; and (x) Physical hazards. (1) Every establishment shall develop and implement a written HACCP plan covering each product produced by that establishment whenever a hazard analysis reveals one or more food safety hazards that are reasonably likely to occur, based on the hazard analysis conducted in accordance with paragraph (a) of this section, including products in the following processing categories: (i) Slaughter - all species. Critical limits shall, at a minimum, be designed to ensure that applicable targets or performance standards established by FSIS, and any other requirement set forth in this chapter pertaining to the specific process or product, are met; (4) List the procedures, and the frequency with which those procedures will be performed, that will be used to monitor each of the critical control points to ensure compliance with the critical limits; (5) Include all corrective actions that have been developed in accordance with § 417.3(a) of this part, to be followed in response to any deviation from a critical limit at a critical control point; and (6) Provide for a recordkeeping system that documents the monitoring of the critical control points. food processing sector is extensively regulated by state and federal agencies.
This presentation from IVT Network's Method Validation Conference covers required and suggested regulations and guidances for biological process specifications.
For the manufacture of biologicals such as recombinant proteins, enzymes, monoclonals and gene therapy vectors, many cell culture systems are used which require additives derived from bovine or porcine origin such as fetal bovine or newborn calf sera, insulin, transferrin, growth factors and trypsin.
Testing the critical raw materials that are used in the biological manufacturing process can greatly minimize the risk of contamination.
is any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals.
The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect.