An MD&DI February 1997 Feature Article
FDA Makes Quality the Rule (continued)
2. PURCHASING CONTROLS
As embodied in the new regulation, purchasing controls (subpart E) are new requirements that compel manufacturers to assess the capability of suppliers, contractors, and consultants to provide acceptable products and services before they are delivered. The overall intent of these purchasing requirements is to provide a greater degree of assurance for product and service quality, beyond that provided by inspection and testing. In this connection, the term services pertains to manufacturing or quality assurance activities, such as plating, testing, or sterilization, for which other companies or individuals are contracted.
Manufacturers should note that the purchasing requirements also apply to manufacturing materials, because the regulation's definition of product includes manufacturing materials. The preamble to the regulation also makes it clear that these requirements apply to manufacturing-material suppliers (comment 101). Firms whose current procedure for the acceptance of manufacturing materials consists of simply checking the products' brand names may have to upgrade that procedure if unacceptable manufacturing materials could have an adverse effect on their devices. Manufacturers should review all manufacturing materials and categorize them according to the effect their failure to meet requirements would have on the product. Acceptance controls should then be established as appropriate for each category of materials.
The preferred method for assessing suppliers is an on-site audit, but the regulation does not mandate audits, and manufacturers have other options. For example, assessment of suppliers may be accomplished through review of historical data, trending of acceptance data, or inspection and testing. When manufacturers choose supplier audits as the assessment method, the audit reports are not subject to FDA review or copying (820.180(c)). However, the audit procedures, schedules, and evaluation methods will be subject to FDA scrutiny.
The 1978 GMP regulation contained the requirement for suppliers to notify manufacturers of any changes in their products (820.81(b)), but it was then applied only to critical component suppliers. The new requirement (820.50(b)) applies to all component suppliers. The section on purchasing data (820.50(b)) requires manufacturers to establish controls to ensure that the requirements for products and services are clearly defined, and mandates the use of quality requirements in purchasing documents. The latter requirement is not well understood by some manufacturers. These quality requirements pertain to quality control and quality assurance procedures and standards, and any other procedures that may be necessary to ensure that products and services conform to specifications. For a manufacturer to comply with the regulation, these quality requirements must be agreed upon and specified, or referenced, in the purchasing documents. In practice, these requirements are often connected with plans or drawings that manufacturers provide to suppliers in order to describe product specifications. Quality requirements can also be established by reference to published standards. When this method is used, manufacturers should be specific about which part of the standard applies, since many standards contain multiple tests.
The requirement to approve purchasing data applies to the review and approval of purchasing documents in order to ensure that their requirements are clear. It does not relate to the purchasing transaction itself.
