Supplier certification

Current good manufacturing practices (CGMPs) indicate that a parenteral manufacturer should confirm supplier certification on packaging components. The following characteristics are usually monitored for a specific elastomeric formulation ... 

Tablets and capsules Pharmaceutical ingredients Purified water Manufacturing environment Products Periodic after history is established accepted on supplier certificate of analysis Loop daily and taps weekly Quarterly Periodic after history is established due to low water activities of tablets and capsules...

After successful vendor auditing, it can be determined whether purchased ingredients and materials can be accepted on the basis of suppliers certificates, with minimized inspections of incoming goods to a certain level. Vendor certification leads to reduction of costs and release times. 

Raw materials must always be approved by the Quality Unit before use by production. Each lot of raw material should be sampled and the laboratory should perform at least an identity test in addition to verifying from the supplier Certificate of Analysis (COA) that the lot test results conform to the excipient manufacturer s specification. Upon approval, the status of the lot is changed from unapproved or quarantine to approved or available. The raw material lot status can be identified by use of approval labels on the container or pallet, movement of the raw material lot to the approved section of the warehouse, or by changing the lot status in a computerized inventory system. 

Supportive documentation should be added to the report, such as equipment and facility drawings, technical and other specifications, test methods, suppliers certificates, health authorities approvals, approvals of components, and raw data results. 

A color technician tests 3-10 batch samples on each piece of equipment two to three times each. The AV now becomes appraisal reproducibility for each EV piece of plastics dispersion equipment. This technique is also useful for comparing supplier Certificate of analysis (COA) data against your own incoming quality control (QC) testing to determine reliability between the two sets of data. To accomplish this, you must request duplicate sets of color data for each lot over 3-10 consecutive lots. 

All starting materials must be tested or otherwise verified prior to use. Verification should include a supplier Certificate of Analysis and, wherever feasible, at least an identification test There should be dear guidelines established for the approval of each starting material. 

At least one test should be conducted to verify the identity of each raw material. A supplier s certificate of analysis might be used in lieu of performing other testing provided that the manufacturer has a system in place to evaluate vendors and establishes the reliability of the supplier s test results at appropriate intervals. For hazardous or highly toxic raw materials, where on-site testing may be impractical, suppliers certificates of analysis should be obtained showing that the raw materials conform to specifications. In addition, the identity of these raw materials should be confirmed by examination of containers and labels. The lack of on-site testing for hazardous raw materials should be documented. 

A brief synopsis of the test methods for raw materials is generally sufficient, and validation data have, to date, not been required in the original application. For items accepted based on supplier certificates, it is still necessary in most cases to list either the company s or the supplier s tests and acceptance criteria. 

Gas cylinders are commonly used for process MS calibration because of their relative simplicity and economy. Cylinders should be prepared gravimetrically, ideally by a supplier experienced in the preparation of accmate trace gas mixtures. Caution must be ejKrcised in relying completely on gas cylinder suppliers certificates of analysis, and it is frequently advisable to validate cylinders via another primary technique such as GC, although one should first scmtinize how that primary technique is itself calibrated. Stability of the gas mixture must be checked. PTFE-hn-ings and electropolished cylinder interiors are often used to slow degradation. 

Having selected a supplier, Chapter 6 introduees a proeedure for their effective implementation. This is the begiiming stage of the supplier certification process. 

For TSCA purposes, TSCA import certifications should be kept for five years and any documents used in determining the compliance of the substance with TSCA (such as supplier certification letters, MSDS and the Kke) for five years from the date of last import of the product, since the company will be relying on those documents the entire time it imports the product, not just the first time. 

Recent newspaper articles focused on lead paint used on Thomas the Tank Engine toys, industrial chemicals in toothpaste, industrial and not pharmaceutical ingredients in children s medicine, chemicals in children s toys that can convert to harmful chemicals when ingested, and contamination of dog food products all indicate that certifying supplier quality in a supply chain is an important component of the purchasing function. However, in the absence of easy-to-perform quality assurance testing, supplier certification and contract incentives play an important role in guaranteeing product quality. 

The other tools that are used with JIT are often used with many other systems and are discussed separately. Some of these include total quality management, supplier certification/management, and supply chain management. 

Grieco, P. L., Jr., Supplier Certification II Handbook for Achieving Excellence through Continuous Improvement, 5th edition, West Palm Beach, FL PT Publications, Inc., 1996. 

Capital equipment aftermarket parts distributor All markets and customers All products supported Sourcing group responsible for selection and business arrangement negotiation with suppliers for high-value commodity groups, supplier certification, and supplier performance measurement... 

Incoming/ outgoing material qualification/ certification plan The supplier must show how it controls the quality of incoming and outgoing material. Examples include inspection of incoming material, receiving/shipping reports, and supplier certifications. 

In the past 10 years, an increasing number of businesses and major corporations are requiring suppliers to be certified. The trend toward supplier certification has evolved from the renewed interest in quality assurance and greater competition from abroad. 

Manage mem is part of improvement team Zero-defects Is the only acceptable method Supplier certification is a way of life... 

Proper quality control of all incoming raw materials, especially PVC resin, is a must. Supplier Certificates of analyses on all shipments are necessary, and spot checks of moisture, bulk density, particle size distribution (percent fines), dry flow, heat stability, and fusion can be very helpful. 

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