Pennsylvania Code
Title 28 - HEALTH AND SAFETY
Part III - Prevention of Diseases
Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS
Subchapter A - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS
GOOD MANUFACTURING PRACTICE IN MANUFACTURE, PROCESSING, PACKING OR HOLDING OF DRUGS
Section 25.11 - Buildings

Universal Citation: 28 PA Code § 25.11

Current through Register Vol. 54, No. 44, November 2, 2024

Buildings shall be maintained in a clean and orderly manner and shall be of suitable size, construction, and location to facilitate adequate cleaning, maintenance, and proper operations in the manufacturing, processing, packing, labeling or holding of a drug. The buildings shall conform with the following:

(1) Provide adequate space for the following:

(i) Orderly placement of equipment and materials to minimize any risk of mixups between different drugs, drug components, in-process materials, packaging materials or labeling, and to minimize the possibility of contamination.

(ii) The receipt, storage and withholding from use of components pending sampling, identification, and testing prior to release by the materials approval unit for manufacturing and packaging.

(iii) The holding of rejected components prior to disposition to preclude the possibility of their use in manufacturing or packaging procedures for which they are unsuitable.

(iv) The storage of components, containers, packaging materials, and labeling.

(v) Any manufacturing and processing operations performed.

(vi) Any packaging or labeling operations.

(vii) Storage of finished products.

(viii) Control and production-laboratory operations.

(2) Provide adequate lighting, ventilation and screening and, when necessary for the intended production or control purposes, provide facilities for adequate air-pressure, microbiological, dust, humidity and temperature controls to insure the following:

(i) Minimize contamination of products by extraneous adulterants, including cross-contamination of one product by dust or particles of ingredients arising from the manufacture, storage or handling of another product.

(ii) Minimize dissemination of micro-organisms from one area to another.

(iii) Provide suitable storage conditions for drug components, in-process materials and finished drugs in conformance with stability information as derived under § 25.21 (relating to stability).

(3) Provide adequate locker facilities and hot and cold water washing facilities, including soap or detergent, air dryer or single service towels and clean toilet facilities near working areas.

(4) Provide an adequate supply of potable water under continuous positive pressure in a plumbing system free of defects that could cause or contribute to contamination of any drug. Drains shall be of adequate size and, where connected directly to a sewer, shall be equipped with traps to prevent back-siphonage.

(5) Provide suitable housing and space for the care of all laboratory animals.

(6) Provide for safe and sanitary disposal of sewage, trash and other refuse within and from the buildings and immediate premises.

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