Material specification approved suppliers

In the case of noncompendial materials, specifications and complete descriptions of the test methodologies to be used for quality control release purposes by the sponsor should be included. In addition, it may be necessary for the sponsor to obtain a letter authorizing reference to a DMF from the supplier concerning the manufacturing and controls procedures used to make these materials, such as mixtures of colorants or flavors. It may be necessary to obtain toxicity data if the mixture or component has little or no history of human use (e.g., new polymers). If it is anticipated that an untried component will be used, it is recommended that discussions be initiated with the FDA s reviewing chemist and pharmacologist. These sessions should be scheduled as soon as possible to minimize the possibility of delays in NDA approval caused by inadequate information to support use of the material. 

The quality control department should have responsibility together with other relevant departments for approving suppliers who can reliably supply starting and packaging materials that meet established specifications. 

APPROVED SUPPLIER A supplier of starting materials of known origin who is recognised as reliable, based on a history of deliveries which all met specifications and were well packaged and intact on receipt and, where possible, based also on a vendor audit (see also Certified Supplier). 

When materials are received to be used in the manufacture of a pharmaceutical product, an inspection (and possible testing) is usually necessary before the materials are accepted. Materials may be stored in a separate quarantined area until they are released and approved for use. The use of certified suppliers has allowed some materials to be received and accepted without additional inspection or testing. The certified supplier may provide a certificate of analysis dociimenting that the material meets the required specifications. Certified suppliers are usually audited to insure that they meet the requirements for certification of the customer. 

This activity includes information on contractual arrangements with suppliers and points of contact, relationship history (orders, fulfillments, disputes, resolutions), business evaluations, and technical evaluations of products and capabilities, including certifications for specific materials. For specific materials (or product families), there are approved supplier lists that identity supphers from whom the organization may order that material, often with preference ranking or ranking criteria. 

Step 11. Upon receipt of all the approvals noted in this procedure, including the execution of a supply contract, the suppher is added to the list of approved suppliers for the specific raw material. 

The attribute assessment determines whether the container materials meet the specifications. A risk assessment should be performed to determine what level of quality assessment needs to be undertaken. This risk assessment should take into consideration the level of quality assessment performed by the manufacturer or supplier. For example, if the manufacturer has a limited quality assessment system, then the purchaser may be required to carry out an extensive number of checks. An audit of the manufacturer is the best way to determine what level of assessment needs to be undertaken by the purchaser. An audit may be part of certification or accreditation of the manufactiuer or the supplier. Audit findings can provide a list of so-called reliable suppliers (see also Sect. 21.5.1). The level of quality control imdertaken by a container manufactiuer can be obtained from one of these audit reports. When using an established approved supplier, a purchaser could reduce the amount of testing that needs to be undertaken. For example the level of testing could be reduced to an identity test and assessment of the supplier s certificate of conformity. A limited identity test could include dimensions, colour and text. Additional tests for parenteral product containers could include ... 

Military applications tend to be more dispersed than aerospace applications, however, often with relatively small potential volumes, plus a somewhat longer application development, approval, and procurement cycle. Fortunately, product life cycles tend to be relatively long. Both aerospace and military markets tend to be kinder to material suppliers than processors. Once a material specification is written around a particular product tightly enough, end users and your competitors alike will have difficulty justifying the time and cost required to qualify alternate sources. 

In terms of individual parts, the materials that are selected will typically be described in a material specification, either on a part drawing, or in a material specification document. This material specification will describe the chemical family, the type (homopolymer, copolymer, etc.), the additives, perhaps the color (or lack thereof), and more. It may even reference some standard property values of the material and specific product codes from approved suppliers. 

A common practice in material specifications is to provide a list of one or more approved material suppliers. This is usually done in conjunction with the supplier product code for the material that has been specified. There are many reasons for doing this. It provides a confirmation that the material you specified will be used, exactly as you specified. This supplier may have a reputation for quality, reliability, and global availability. It also provides the foundation for a long-term business relationship. You are rewarding the resin supplier for the technical support they provided... 

Specifications are normally written by QC personnel. They detail the exact qualitative and quantitative requirements to which individual raw materials or product must conform. For example, specifications for chemical raw materials will set strict criteria relating to the percentage active ingredients present, permitted levels of named contaminants, etc. Specifications for packing materials will, for example, lay down exact dimensions of product packaging cartons specifications for product labels will detail label dimensions and exact details of label text, etc. Specifications for all raw materials are sent to raw material suppliers and, upon their delivery, QC personnel will ensure that these raw materials meet their specifications before being released to production (the raw materials are held in quarantine prior to their approval). Final product specifications will also be prepared. As most products are manufactured to conform with pharmacopoeial requirements, many of the specifications set for raw materials/finished product are simply transcribed from the appropriate pharmacopoeia. 

Even though full GMP compliance may begin later than receipt of raw materials, it is important to treat raw materials in a GMP compliant manner. Raw materials should be purchased only from suppliers approved by the Quality Unit. For raw materials whose quality is important to conformance of the excipient to compendial or specification requirements, or to performance expectations, the supplier approval process should be a combination of site visit and an evaluation of raw material quality. For other raw materials, it would be adequate to confirm that the raw material supplier can meet the purchasing specification. 

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. 

The starting materials as well as the packaging materials should be purchased from qualified vendors. It is recommended to use materials described in a pharmacopoeia, whenever this is available. Supplier approval should include an evaluation that provides adequate assurance that the material consistently meets specifications. 

Before suppliers are approved and induded in the specifications they should be evaluated. The evaluation should take into account a supplier s history and the nature of the materials to be supplied. If an audit is required, it should determine the supplier s ability to conform with GMP standards for active pharmaceutical ingredients (see section 18). 

Testing schedules may take into account the nature and age of the material, the grading and history of the supplier, and any valid certificate of analysis. A valid certificate of analysis is one from an approved or certified supplier (see Glossary) which relates to a specific batch of material and which is in the proper form, dated and signed. It does not include a certificate of average or typical composition. 

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