We offer a variety of GMP services ranging from SOPs, Procedures, and Records; Specifications; Master Manufacturing and Batch Production Records; and Testing.
Procedures (SOPs) & Records
The most common cGMP citation in Warning Letters issued to the dietary supplement industry is a lack of procedures and records. Fourteen out of 16 Part 111 Subparts require a documented procedure with an accompanying record as evidence it was followed. With 20 years of quality and product development experience and countless successful audits we can help you document your systems in way that meets the regulatory requirements and reduces your risk.
Our stock SOPs have been scrutinized during numerous successful audits and have been written to meet the highest level of auditor scrutiny. Dietary Supplement Experts specializes in preparing SOPs that are succinct, effective and easy to follow. We offer a wide range of SOPs and Records that cover the full range of the 21 CFR Part 111 requirements, including:
- Customer Complaints
- Cleaning Procedures
- Quality Responsibilities
- Receiving Inspections
- Supplier Qualification
- Corrective Action/Preventive Action
- Material Reviews/Investigation
- Product Returns
For clients with existing SOPs and records, Dietary Supplement Experts can work with your team to review them against the Part 111 sections and prepare a gap analysis to outline any opportunities.
Specifications are the foundation upon which you products are built. The 21 CFR Part 111 regulations require that specifications be established for,
- Components: Identity, Both Dietary and Other Ingredients, Botanicals, Extracts, Vitamins, Minerals, etc.
- In-Process: Pharmacy, Blending, Encapsulation, Tableting, Coating, Packaging, etc.
- Packaging: Bottles, Lids, Seals, etc.
- Products: Finished Goods
- Bulk: Product received packaging and/or labeling
Dietary Supplement Experts has extensive experience creating specifications and will help you determine the tests, methods and limits are most appropriate to ensure the quality of your product. We have templates which incorporate all the Part 111 requirements as outlined in Section s 70 and 75.
In addition, we can help you document the basis for why meeting them will ensure the quality of the finished product.
For clients with existing specifications, Dietary Supplement Experts can work with your team to review them against Part 111 Section 70 and 75 and prepare a gap analysis to outline any opportunities.
Master Manufacturing and Batch Production Records
21 CFR Part 111, section 205 states there must be a written master manufacturing record (MMR) for each unique formulation and each unique batch size of a manufactured dietary supplement. The master manufacturing records ensure your manufacturing process is performed consistently and uniformly from batch to batch.
You must also have a batch production record (BPR) every time a dietary supplement batch is made. The batch production record must accurately follow the appropriate master manufacturing record. If deviations from the batch record occur, these must be documented and the quality unit must investigate and approve each deviation before the batch can be released.
Dietary Supplement Experts can help you are create an MMR and BPR template that suits your particular system while still meeting the regulatory requirements. We specialize in customizing our templates to your systems. With over 20 years of experience in the dietary supplement industry and many successful audits we have creative insights on MMRs and BPRs. Dietary Supplement Experts will work with your team to create a system which withstands the scrutiny of the FDA and ensures product quality.
For clients with existing MMRs and BPRs, Dietary Supplement Experts can work with your team to review them against the Part 111 sections and prepare a gap analysis to outline any opportunities.
In order to provide quality dietary supplements, testing and controls are necessary as described in the FDA’s Final Rule on GMP Dietary Supplements and in Part 111, section 75. Botanicals are often complex and can vary in composition depending on factors such as the part of the plant used, the location of harvesting and growing conditions that can vary from year to year even in the same location.
It is important to distinguish between closely related species of botanicals, since the biological activity of an incorrectly identified species can lead to adverse consequences. Also, different species may show up in different ratios in a particular product. Each manufacturer must perform 100% identity testing to verify the identity of each dietary ingredient and each component used in the final product prior to manufacturing. In addition, each dietary ingredient has to be tested for potency and purity.
These challenges make it essential that appropriate tests and methods are developed and used for controlling the dietary ingredients that are included in the final product. Dietary Supplement Experts can help you to determine the best course of action so that testing meets the regulatory requirements while keeping the costs in check. We have over 20 years of experience developing test plans that cover all the major dietary supplement categories, such as Botanicals, Extracts, Vitamins and Minerals.
For clients with existing test plans, Dietary Supplement Experts can work with your team to review them against the Part 111 sections and prepare a gap analysis to outline any opportunities.