Or. Admin. R. 855-060-0005 - General Provisions and Minimum Standards

In order to qualify for a manufacturing registration, the applicant shall meet certain minimum standards:

(1) Organization: The physical plant of the manufacturer shall be properly organized with adequate facilities and qualified personnel to operate the same under the direction of a technically trained or professionally competent supervisor:

(a) The production supervisor in charge shall be responsible to the proper administrative authority of the manufacturer for the developing, supervising, and coordinating of all the activities of the manufacturing plant so far as production techniques are involved;

(b) Departmentalization shall follow good administrative procedure integrated with the administration of the manufacturing firm in general;

(c) The organizational structure of the manufacturing operation may vary depending upon the size and character of the particular products manufactured. (It is not the intent of the minimum standard requirements set out in the rules herein provided to cast all manufacturers in the same mold, although it is their intent to assure the establishment of fundamental principles which will enable competent production with sufficient freedom to supply the demand for adequate pharmaceutical products.)

(2) Policies: The production supervisor in charge, with approval of the director or other proper administrative or executive authority of the manufacturer, shall initiate and develop rules and regulations pertaining to the manufacturing procedures of the firm or producer. Such policies and procedures established by rule and regulation shall conform with techniques currently practiced in the other pharmaceutical industries of a similar kind. (The spirit of the minimum standard requirements for licensees is one of helpful cooperation.)

(3) Personnel: The production supervisor in charge shall be a person adequately trained in the specialized functions required for manufacturing of pharmaceutical products and may be required to submit properly attested documents of proof of formal education qualifying him for this position. He shall have such assistants as the volume of work in the plant may dictate. The personnel shall also include such additional technically trained persons as the activities of the manufacturer may require to supply pharmaceutical service of the highest quality. The adequacy of the personnel will be determined by the size and scope of the manufacturing operation.

(4) Facilities: Adequate pharmaceutical and administrative facilities shall be provided including particularly:

(a) Essential manufacturing equipment to process properly the products to be manufactured;

(b) An adequate, up-to-date library for information concerning drugs and pharmaceutical products;

(c) Refrigeration for storage of thermolabile products;

(d) Adequate floor space;

(e) Sanitary facilities, lighting, ventilation, and plant safety as prescribed by the Workers Compensation Department, the Occupational Safety and Health Division.

(5) Products Control: Pharmaceutical manufacturing operations require facilities for chemical, physical and usually biological and bacteriological testing. The extent of laboratory facilities required for products control depends upon the products to be manufactured, the specifications and standards they are required to meet, and the raw materials involved in their production. If the manufacturing process is not large enough to justify the maintenance of a products control staff, the manufacturer's samples or products shall be sent to a competent laboratory for control checking of the manufactured product.

(6) Manufacturing of drug substances shall be separated from manufacturing of food substances.

Notes

Or. Admin. R. 855-060-0005

1PB 18, f. & ef. 10-14-64; 1PB 23, f. 2-14-74, ef. 3-11-74; 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80

Stat. Auth.: ORS 689

Stats. Implemented: