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Quality control corner: factory auditing process
7/13/2018 11:18 AM
ingredientsonline.com recently sent our QA auditor, Kevin Chen, to audit three of our factory partners: Shandong Jinpharm, Jingjing Pharmaceutical and Suqian Modern Biology Technology. Kevin performed a full facility inspection, which included the production rooms, warehouse, laboratories and other areas of interest. He also reviewed their documentation system for product testing, warehouse management, personnel management and environmental consciousness. After evaluating the information gathered from his on-site audits, Kevin has determined that, while there is always room for improvement, these three factories have the appropriate systems and procedures in place to be compliant with regulatory requirements.
Shandong Jinpharm Co., Ltd, established in 2015, is a scientific and technological innovation-oriented company that specializes in plant extracts, natural products and research on pharmaceutical intermediates.
The factory operates in accordance to their written HACCP plans and Food Safety systems, which includes detailed procedures and documents to ensure critical steps regarding product safety and quality are maintained. Preventative measures are in place to minimize microbial contamination in operating areas. The company has an effective supplier qualification program and written procedures on handling incoming receipts, raw material inspection and testing requirements. Their allergen control procedure is adept at preventing cross-contamination between allergenic and non-allergenic ingredients. Their manufacturing records are also well organized and include records for non-conformance issues and reprocessing steps. Additionally, while they have not had to use it, Shandong Jinpharm proved that their product recall procedure is effective and well-established in the event of a product health or safety issue.
Kevin advises the company to better identify potential areas of product non-conformance, but overall, the company’s procedures are well-developed and few issues were found.
In recent years, Jingjing Pharmaceutical has shifted the focus of their production to dietary supplement raw materials with an emphasis on fermented amino acids. With that shift in focus, the company has devoted more effort into compliance with relevant regulatory requirements, including the FDA CFRs outlined in Title 21.
The company has systematic standard procedures for cGMP-related practices, including raw material receiving, sampling, inspection & release, allergen control and production process controls. Related documentation and records of standard procedures are readily available and demonstrate consistent adherence to those procedures. The organization of their production records were particularly noted as a confidence booster in product traceability in the event of an issue. The company’s complaint and investigation procedures meet all necessary requirements to properly analyze and close an issue, including a complete analysis of the case, proposed corrective actions and follow up reports to corrective actions. The production areas were also impressive with clearly designated and physically separated “clean” and “non-clean” areas. Jingjing Pharmaceutical maintains Kosher and Halal certification on many of their products, and their facility is certified to ISO 9001 and ISO 14001 standard.
After concluding his on-site inspection, Kevin feels the company could strengthen their pest control program and increase their testing spectrum to include more physical specifications on their products. He emphasized control on physical attributes such as density and particle size and improving warehouse conditions for personnel. Overall, Kevin is confident in the company’s ability to continuously produce quality products. They have demonstrated their management system is effective and they have proper control over production operations.
Suqian Modern Biological Technology Co.’s motto is to adhere to the principles of being “people-oriented, customer-first, quality-best and benefit-sharing.” The company specializes in mineral phosphates and manufactures a wide variety of products for various industries.
In order to improve the level of quality and service delivered, Suqian Modern completely redesigned their facility to adhere to cGMP standards. Their operations are certified to ISO 9001 and HACCP-based ISO 22000 standards. The company also maintains Kosher and Halal certification on their products. During his audit, Kevin observed that the factory has a Food Safety system which includes written procedures that cover all processes critical to product safety and quality such as supplier qualification. Each procedure was thoughtfully written and includes relevant requirements for design, review, verification and validation. Each procedure had the necessary documentation to ensure they were properly being followed. Furthermore, the effectiveness of their HACCP and Food Safety plans are periodically verified to continuously ensure the quality of their product.
Based on the findings of his on-site audit, Kevin recommends that the factory strengthens their enforcement of Personal Protective Equipment usage. Otherwise, Kevin was pleased with the factory’s procedures and their compliance to cGMP and food safety requirements.