An MD&DI February 1997 Feature Article
FDA Makes Quality the Rule (continued)
9. HANDLING, STORAGE, DISTRIBUTION, AND INSTALLATION
Requirements for handling, storage, distribution, and installation are specified in subpart L of the new regulation. The requirements for handling are the same as those that FDA has always required, but now written procedures must be used to define the company's methods. These requirements are the same as in the 1995 working draft.
The storage requirements incorporate those previously included in the 1978 GMP regulation (820.80(b)). In addition, written procedures must be established to define how storage areas and stored products will be controlled. The requirements are the same as those proposed in the 1995 working draft.
The distribution section combines the general and critical device distribution requirements of the 1978 GMP regulation. The only significant change from the 1995 working draft is the addition of a requirement that purchase orders be reviewed to ensure that ambiguities and errors are resolved before devices are released for distribution. The purpose of this addition is to harmonize the new regulation with the contract review requirements of ISO 9001 and ISO 9002 (clause 4.3).
The installation requirements of the new quality system regulation differ from those contained in the 1978 GMP regulation, but are the same as those proposed in the 1995 working draft. They require written installation, inspection, and test instructions regardless of who installs the device, and inspection and test results must be documented.
