Source: https://app.leg.wa.gov/WAC/default.aspx?cite=246-895&full=true
Timestamp: 2020-06-02 10:48:47
Document Index: 704784124

Matched Legal Cases: ['§ 246', '§ 360', '§ 360', '§ 246', '§ 246', '§ 360', '§ 360', '§ 246', '§ 360', '§ 360', '§ 246', '§ 246', '§ 360', '§ 360', '§ 246', '§ 246', '§ 360', '§ 246', '§ 360', '§ 360', '§ 246', '§ 246', '§ 360', 'art 1700', '§ 246', '§ 246', '§ 360', '§ 360', '§ 246', '§ 360', '§ 246', '§ 246', '§ 360', '§ 246', '§ 246', '§ 360']

Chapter 246-895 WAC:
WACs > Title 246 > Chapter 246-895
Chapter 246-895 WAC
PHARMACY—GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
HTMLPDF 246-895-010 Definitions.
HTMLPDF 246-895-020 Finished pharmaceuticals—Manufacturing practice.
HTMLPDF 246-895-030 Personnel.
HTMLPDF 246-895-040 Buildings or facilities.
HTMLPDF 246-895-050 Equipment.
HTMLPDF 246-895-060 Production and control procedures.
HTMLPDF 246-895-070 Components.
HTMLPDF 246-895-080 Component and drug product containers and closures.
HTMLPDF 246-895-090 Reuse of teat dip containers and closures.
HTMLPDF 246-895-100 Laboratory controls.
HTMLPDF 246-895-110 Stability.
HTMLPDF 246-895-120 Expiration dating.
HTMLPDF 246-895-130 Packaging and labeling.
HTMLPDF 246-895-140 Master production and control records—Batch production and control records.
HTMLPDF 246-895-150 Distribution records.
HTMLPDF 246-895-160 Complaint files.
HTMLPDF 246-895-170 Variance and procedure.
PDF246-895-010
(1) As used in these regulations, "act" means the Uniform Food, Drug and Cosmetic Act, chapter 69.04 RCW.
(2) The definitions and interpretations contained in the act shall be applicable to such terms used in these regulations.
(3) As used in these regulations:
(a) The term "component" means any ingredient intended for use in the manufacture of a drug product, including those that may not appear in the finished product.
(b) The term "drug product" means a finished dosage form (e.g., tablet, capsule, solution) that contains an active drug ingredient generally, but not necessarily, in association with inactive ingredients. The term also includes a finished dosage form that does not contain an active ingredient but is intended to be used as a placebo.
(c) The term "active ingredient" means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans or other animals. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in that drug product in a modified form intended to furnish the specified activity or effect.
(d) The term "inactive ingredient" means any component other than an "active ingredient" present in a drug product.
(e) The term "batch" means a specific quantity of a drug or other material that has uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.
(f) The term "lot" means a batch or a specific identified portion of a batch having uniform character and quality within specified limits; or, in the case of a drug product produced by continuous process, it is a specific identified amount produced in a unit of time or quantity in a manner that assures its having uniform character and quality within specified limits.
(g) The terms "lot number," "control number," or "batch number" mean any distinctive combination of letters, numbers, or symbols, or any combination of them, from which the complete history of the manufacture, processing, packing, holding, and distribution of a batch or lot of drug product or other material can be determined.
(h) The term "quality control unit" means any person or organizational element having the authority and responsibility to approve or reject components, in-process materials, packaging components, and final products.
(i) The term "strength" means:
(i) The concentration of the drug product (for example, w/w, w/v, or unit dose/volume basis); and/or
(j) The term "fiber" means any particulate contaminant with a length at least three times greater than its width.
(k) The term "nonfiber-releasing filter" means any filter, which after any appropriate pretreatment such as washing or flushing, will not release fibers into the component or drug product that is being filtered. All filters composed of asbestos are deemed to be fiber-releasing filters.
(l) The term "manufacture" means the production, preparation, propagation, compounding, or processing of a drug or other substance or device or the packaging or repackaging of such substance or device, or the labeling or relabeling of the commercial container of such substance or device, but does not include the activities of a practitioner who, as an incident to his or her administration or dispensing such substance or device in the course of his or her professional practice, prepares, compounds, packages or labels such substance or device.
[Statutory Authority: RCW 18.64.005 and chapter 18.64A RCW. WSR 91-18-057 (Order 191B), recodified as § 246-895-010, filed 8/30/91, effective 9/30/91. Statutory Authority: RCW 18.64.005. WSR 88-21-025 (Order 220), § 360-46-010, filed 10/10/88; Order 133, § 360-46-010, filed 8/4/77.]
PDF246-895-020
Finished pharmaceuticals—Manufacturing practice.
(1) The criteria in WAC 246-895-040 through 246-895-160, inclusive, shall apply in determining whether the methods used in, or the facilities or controls used for, the manufacture, processing, packing, or holding of a drug conform to or are operated or administered in conformity with current good manufacturing practice to assure that a drug meets the requirements of the act as to safety and has the identity and strength and meets the quality and purity characteristics which it purports or is represented to possess as required by the act.
(2) The regulations in this chapter permit the use of precision automatic, mechanical, or electronic equipment in the production and control of drugs when written inspection and checking policies and procedures are used to assure proper performance.
[Statutory Authority: RCW 18.64.005. WSR 92-12-035 (Order 277B), § 246-895-020, filed 5/28/92, effective 6/28/92. Statutory Authority: RCW 18.64.005 and chapter 18.64A RCW. WSR 91-18-057 (Order 191B), recodified as § 246-895-020, filed 8/30/91, effective 9/30/91. Statutory Authority: RCW 18.64.005. WSR 88-21-025 (Order 220), § 360-46-020, filed 10/10/88; Order 133, § 360-46-020, filed 8/4/77.]
PDF246-895-030
(1) The personnel responsible for directing the manufacture and control of the drug shall be adequate in number and background of education, training, and experience, or combination thereof, to assure that the drug has the safety, identity, strength, quality, and purity that it purports to possess. All personnel shall have capabilities commensurate with their assigned functions, a thorough understanding of the manufacturing or control operations they perform, the necessary training or experience, and adequate information concerning the reason for application of pertinent provisions of this part to their respective functions.
(2) Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drugs shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products. All employees shall be instructed to report to supervisory personnel any conditions that may have such an adverse effect on drug products.
[Statutory Authority: RCW 18.64.005 and chapter 18.64A RCW. WSR 91-18-057 (Order 191B), recodified as § 246-895-030, filed 8/30/91, effective 9/30/91. Statutory Authority: RCW 18.64.005. WSR 88-21-025 (Order 220), § 360-46-030, filed 10/10/88; Order 133, § 360-46-030, filed 8/4/77.]
PDF246-895-040
Buildings or facilities.
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, repacking, labeling, or holding of a drug. The buildings shall:
(1) Provide adequate space for:
(a) Orderly placement of equipment and materials to minimize any risk of mixups between different drugs, drug components, drug products, in-process materials, packaging materials, or labeling, and to minimize the possibility of contamination.
(b) The receipt, storage, and withholding from use of components pending sampling, identification, and testing prior to release by the quality control unit for manufacturing or packaging.
(c) 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.
(d) The storage of components, containers, packaging materials, and labeling.
(e) Any manufacturing and processing operations performed.
(f) Any packaging or labeling operations.
(g) Storage of finished products.
(h) 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:
(a) 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.
(b) Minimize dissemination of micro-organisms from one area to another.
(c) Provide suitable storage conditions for drug components, in-process materials, and finished drugs in conformance with stability information as derived under WAC 246-895-110.
(3) Provide adequate locker facilities and hot and cold water washing facilities, including soap or detergent, air drier 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.
(7) Be maintained in a clean, orderly, and sanitary condition. There shall be written procedures assigning responsibility for sanitation and describing the cleaning schedule and methods.
[Statutory Authority: RCW 18.64.005. WSR 92-12-035 (Order 277B), § 246-895-040, filed 5/28/92, effective 6/28/92. Statutory Authority: RCW 18.64.005 and chapter 18.64A RCW. WSR 91-18-057 (Order 191B), recodified as § 246-895-040, filed 8/30/91, effective 9/30/91. Statutory Authority: RCW 18.64.005. WSR 88-21-025 (Order 220), § 360-46-040, filed 10/10/88; Order 133, § 360-46-040, filed 8/4/77.]
PDF246-895-050
PDF246-895-060
PDF246-895-070
PDF246-895-080
Component and drug product containers and closures.
(1) Component and drug product containers and closures shall:
(a) Not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quantity, or purity of the product or its components beyond the official or established requirements;
(b) Provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product; and
(c) Be clean and, where indicated by the nature of the drug, sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.
Containers and their components for parenterals shall be cleansed with water which has been filtered through a nonfiber-releasing filter.
(2) Standards or specifications, methods of testing, and, where indicated, processing to remove pyrogenic properties shall be written and followed for component and drug product containers and closures.
(3) Except as provided for in WAC 246-895-090, drug product containers and closures shall not be reused for component or drug product packaging.
[Statutory Authority: RCW 18.64.005. WSR 92-12-035 (Order 277B), § 246-895-080, filed 5/28/92, effective 6/28/92. Statutory Authority: RCW 18.64.005 and chapter 18.64A RCW. WSR 91-18-057 (Order 191B), recodified as § 246-895-080, filed 8/30/91, effective 9/30/91. Statutory Authority: RCW 18.64.005(11). WSR 88-01-025 (Order 208), § 360-46-081, filed 12/9/87.]
PDF246-895-090
PDF246-895-100
PDF246-895-110
There shall be written procedures for assurance of the stability of finished drug products. This stability shall be:
(1) Determined by reliable, meaningful, and specific test methods.
(2) Determined on products in the same container-closure system in which they are marketed.
(3) Determined on any dry drug product that is to be reconstituted at the time of dispensing (as directed in its labeling), as well as on the reconstituted product.
(4) Recorded and maintained in such manner that the stability data may be utilized in establishing product expiration dates.
[Statutory Authority: RCW 18.64.005 and chapter 18.64A RCW. WSR 91-18-057 (Order 191B), recodified as § 246-895-110, filed 8/30/91, effective 9/30/91. Statutory Authority: RCW 18.64.005. WSR 88-21-025 (Order 220), § 360-46-100, filed 10/10/88; Order 133, § 360-46-100, filed 8/4/77.]
PDF246-895-120
To assure that drug products liable to deterioration meet appropriate standards of identity, strength, quality, and purity at the time of use, the label of all such drugs shall have suitable expiration dates which relate to stability tests performed on the product.
(1) Expiration dates appearing on the drug labeling shall be justified by readily available data from stability studies such as described in WAC 246-895-110.
(2) Expiration dates shall be related to appropriate storage conditions stated on the labeling wherever the expiration date appears.
(3) When the drug is marketed in the dry state for use in preparing a liquid product, the labeling shall bear expiration information for the reconstituted product as well as an expiration date for the dry product.
[Statutory Authority: RCW 18.64.005. WSR 92-12-035 (Order 277B), § 246-895-120, filed 5/28/92, effective 6/28/92. Statutory Authority: RCW 18.64.005 and chapter 18.64A RCW. WSR 91-18-057 (Order 191B), recodified as § 246-895-120, filed 8/30/91, effective 9/30/91; Order 133, § 360-46-110, filed 8/4/77.]
PDF246-895-130
Packaging and labeling operations shall be adequately controlled: To assure that only those drug products that have met the standards and specifications established in their master production and control records shall be distributed; to prevent mixups between drugs during filling, packaging, and labeling operations; to assure that correct labels and labeling are employed for the drug; and to identify the finished product with a lot or control number that permits determination of the history of the manufacture and control of the batch. An hour, day, or shift code is appropriate as a lot or control number for drug products manufactured or processed in continuous production equipment. Packaging and labeling operations shall:
(1) Be separated (physically or spatially) from operations on other drugs in a manner adequate to avoid mixups and minimize cross-contamination. Two or more packaging or labeling operations having drugs, containers, or labeling similar in appearance shall not be in process simultaneously on adjacent or nearby lines unless these operations are separated either physically or spatially.
(2) Provide for an inspection of the facilities prior to use to assure that all drugs and previously used packaging and labeling materials have been removed.
(3) Include the following labeling controls:
(a) The holding of labels and package labeling upon receipt pending review and proofing against an approved final copy by a competent and responsible individual to assure that they are accurate regarding identity, content, and conformity with the approved copy before release to inventory.
(b) The maintenance and storage of each type of label and package labeling representing different products, strength, dosage forms, or quantity of contents in such a manner as to prevent mixups and provide proper identification.
(c) A suitable system for assuring that only current labels and package labeling are retained and that stocks of obsolete labels and package labeling are destroyed.
(d) Restriction of access to labels and package labeling to authorized personnel.
(e) Avoidance of gang printing of cut labels, cartons, or inserts when the labels, cartons, or inserts are for different products or different strengths of the same products or are of the same size and have identical or similar format and/or color schemes. If gang printing is employed, packaging and labeling operations shall provide for added control procedures. These added controls should consider sheet layout, stacking, cutting, and handling during and after printing.
(4) Provide strict control of the package labeling issued for use with the drug. Such issue shall be carefully checked by a competent and responsible person for identity and conformity to the labeling specified in the batch production record. Said record shall identify the labeling and the quantities issued and used and shall reasonably reconcile any discrepancy between the quantity of drug finished and the quantities of labeling issued. All excess package labeling bearing lot or control numbers shall be destroyed. In event of any significant unexplained discrepancy, an investigation should be carried out according to WAC 246-895-060(9).
(5) Provide for adequate examination or laboratory testing of representative samples of finished products after packaging and labeling to safeguard against any errors in the finishing operations and to prevent distribution of any batch until all specified tests have been met.
(6) Provide for compliance with the Poison Prevention Packaging Act, (16 C.F.R. Part 1700).
(7) Provide for compliance with WAC 246-895-080(2).
[Statutory Authority: RCW 18.64.005. WSR 92-12-035 (Order 277B), § 246-895-130, filed 5/28/92, effective 6/28/92. Statutory Authority: RCW 18.64.005 and chapter 18.64A RCW. WSR 91-18-057 (Order 191B), recodified as § 246-895-130, filed 8/30/91, effective 9/30/91. Statutory Authority: RCW 18.64.005. WSR 88-21-025 (Order 220), § 360-46-120, filed 10/10/88; Order 133, § 360-46-120, filed 8/4/77.]
PDF246-895-140
PDF246-895-150
(1) Finished goods warehouse control and distribution procedures shall include a system by which the distribution of each lot of drug can be readily determined to facilitate its recall if necessary. Records within the system shall contain the name and address of the consignee, date and quantity shipped, and lot or control number of the drug. Records shall be retained for at least two years after the distribution of the drug has been completed or one year after the expiration date of the drug, whichever is longer.
(2) To assure the quality of the product, finished goods warehouse control shall also include a system whereby the oldest approved stock is distributed whenever possible.
[Statutory Authority: RCW 18.64.005 and chapter 18.64A RCW. WSR 91-18-057 (Order 191B), recodified as § 246-895-150, filed 8/30/91, effective 9/30/91; Order 133, § 360-46-140, filed 8/4/77.]
PDF246-895-160
Records shall be maintained of all written and oral complaints regarding each product. An investigation of each complaint shall be made in accordance with WAC 246-895-060(8). The record of each investigation shall be maintained for at least two years after distribution of the drug has been completed or one year after the expiration date of the drug, whichever is longer.
[Statutory Authority: RCW 18.64.005. WSR 92-12-035 (Order 277B), § 246-895-160, filed 5/28/92, effective 6/28/92. Statutory Authority: RCW 18.64.005 and chapter 18.64A RCW. WSR 91-18-057 (Order 191B), recodified as § 246-895-160, filed 8/30/91, effective 9/30/91; Order 133, § 360-46-150, filed 8/4/77.]
PDF246-895-170
Licensees may request that the board issue a variance from specific requirements of WAC 246-895-040 through 246-895-160. The request must be in writing and must explain why the criteria should not apply and how the public's safety would be protected. Issuance of a variance shall be based on the information supplied by the manufacturer requesting the variance, as well as any other information available as a result of any investigation by the board and/or any other relevant information available. After due consideration of all the information, the board may issue or deny the requested variance. Any variance granted shall be limited to the particular case described in the request and shall be posted at the manufacturing location during the time it is in effect. Variances will be reviewed at least every three years. Variances shall be subject to withdrawal or modification at any time if the board finds the variance has resulted in actual or potential harm to the public.
[Statutory Authority: RCW 18.64.005. WSR 92-12-035 (Order 277B), § 246-895-170, filed 5/28/92, effective 6/28/92. Statutory Authority: RCW 18.64.005 and chapter 18.64A RCW. WSR 91-18-057 (Order 191B), recodified as § 246-895-170, filed 8/30/91, effective 9/30/91. Statutory Authority: RCW 18.64.005. WSR 88-21-025 (Order 220), § 360-46-160, filed 10/10/88.]