BIO-CAT’s Quality Assurance/Quality Control Director, Julie Litz, featured an article in Natural Products INSIDER’s “Contract Manufacturing: Audits”. As a FSSC (Food Safety System Certification) 22000 certified company and FDA registered facility, BIO-CAT is no stranger when it comes to audits. BIO-CAT’s Quality Control Team provides complete supporting documents including audit records (when requested), specification sheets, and certificates of analysis for every lot of every product. Higher standards yield better results, and BIO-CAT is proud to have obtained certifications proving we have met some of the highest product standards in our industry.
“Audits can be powerful tools in providing observations and feedback between a brand owner and its manufacturer, and allow for establishment of a robust quality manufacturing process.” Litz explained.
With over 25 years of experience in the biotechnology field, Litz is an expert in ensuring the quality and safety of every product manufactured at BIO-CAT. In this article, Litz explains the audit steps and requirements for brand owners and contract manufacturers to ensure GMP responsibilities are met.
“Good manufacturing practices (GMPs) outline the requirements for the manufacturing of finished goods. Brand owners are charged with knowing which GMPs are relevant to a product, and then working with the contract manufacturer to draft a contract to ensure the GMP responsibilities of each company are clearly delineated. Despite using a contractor to manufacture a product, the brand owner is responsible for ensuring all contractual obligations and cGMPs that apply to the finished good are met. A contractor audit is one way of accomplishing this.
The first step of a contractor audit is to assign an auditor that is well trained in auditing based on the required specific regulations. The contract should be thoroughly reviewed, and the auditor should determine if there are any unique elements to consider when auditing the contract manufacturer. The auditor should contact the manufacturer and communicate the purpose of the audit. If available, a checklist the auditor will be using to conduct the audit should be supplied to the contractor. If the audit is unannounced, which can provide a more realistic view of the manufacturer’s day-to-day activities, the auditor should supply this information to the contractor upon arrival at the manufacturing facility.” Litz explained.
“After manufacturing of the product begins, audit frequency should be established. In addition to audits, the brand owner may elect to send a representative to observe the manufacturing process at the facility, which can help confirm the product is being manufactured according to the contractual obligations and the required cGMPs. This should be written into the contract and should be accepted by any reputable contract manufacturer. All appropriately updated documents associated with the audit process should be properly stored and accessible to regulatory authorities.”
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