The first and foremost step for a computer system audit is to prepare a robust computer system validation program which must include : Validation Policy – which talks about various policies you have internally which defines what are the processes you must have and as a company what you will do. Validation Procedure – these Read more about Computer System Audit Preparation Steps[…]
Novel Food defined as food that has not been consumed to a significant degree in the EU before May 15, 1997 AND falls within at least one of 10 categories listed in Article 3 of the new regulation. Determination of Novel Status – Guiding steps: 1.Assess whether the ingredient is excluded from the scope (food Read more about Novel Foods Regulation[…]
Food supplements marketed in a EU Member State have to comply with all relevant aspects of EU food legislation and any specific EU Member State national legislation in terms of their composition, manufacture and control. Food Supplements are considered as “foodstuffs” under the EU General Food Law Regulation (EC) No 178/2002 Required to comply with Read more about Food Supplement Manufacturing & Quality Assurance considerations in EU[…]
The FDA and FTC work together under a long-standing liaison agreement governing the division of responsibilities between the two agencies. The FDA has primary responsibility for claims on product labelling, including packaging, inserts, and other promotional material. The FTC has primary responsibility for claims in advertising, in print and broadcast ads, informercials, catalogues, and digital Read more about FTC Evaluation Process for Advertising Dietary Supplements[…]
While specifically exempted from Subparts C and G of 117, due to overlap with 111, dietary supplement manufacturers/companies have responsibility for compliance with subparts A (General Provisions), B (cGMPs), and F (Records that must be established and maintained). FSMA spells out an exemption to subpart G, – Supply-Chain Program, but these exemptions apply only Read more about 21 CFR 117- FSMA – Current GMPs, Hazard Analysis, and Risk-Based Preventive Controls for Human Food[…]
The bare minimum current good manufacturing practice for preparation of dietary supplements for human consumption consists of 16 subparts with 84 unique requirements. Key requirement below Manufacturers required to implement a system of production and process controls for all stages of the manufacturing, packaging, labeling, quality control, record-keeping, storing, and distributing of DS to ensure Read more about 21 CFR Part 111 – Good Manufacturing Practice (GMP) for Dietary Supplements[…]
A bank’s risk assessment should assist in effectively managing the BSA/AML risk and, therefore, is critical in the development of applicable internal controls, as required for your BSA/AML compliance program. Common Problems with Risk Assessments are: Incomplete Identification of relevant risk factors is . Insufficient detail of a risk factor to evaluate potential risk. Mitigating Read more about BSA Risk Assessment Problems[…]
The cost of compliant CSV can be as much, if not more than the remaining tasks required for system development and implementation. A balance must be reached in order to achieve compliance while minimizing cost of CSV. There are specific industry best practices for effectively controlling the cost of system validation. The cost of longer-term Read more about Best Practices of CSV & 21 CFR Part 11 Compliance[…]
21 CFR Part 11 is a section in the Code of Federal Regulations (CFR) that sets forth the United States Food and Drug Administration’s (FDA) guidelines on using: Electronic records (ER), and electronic signatures (ES). Each title of the CFR addresses a different regulated area: 21 CFR relates to Pharmaceuticals and Medical Devices. Part 11 Read more about Data Integrity & 21 CFR Part 11 Compliance Requirements[…]
A Supplier Management Program should have below elements : Definition of the product’s quality requirements Evaluation of alternative suppliers Selection of the most appropriate suppliers Conduct joint quality planning Co-operation during relationship period Validation of conformance to requirements Certification of qualified suppliers Conduct quality improvement plans Creation and use of supplier rating Guidance for Supplier Read more about Supplier Management Key elements & Guidance[…]