DRAFT- CTFA GUIDELINES FOR COSMETIC GOOD …

1 DRAFT- CTFA GUIDELINES FOR COSMETIC good manufacturing practices Approved by the Quality Assurance Committee March 4, 1999 Table of Contents 3 QUALITY ASSURANCE 3 PERSONNEL 4 PLANT AND GROUNDS 5 EQUIPMENT 6 INSPECTION AND TESTING CONTROL 7 VALIDATION 8 PURCHASE, RECEIPT, AND CONTROL OF MATERIALS 9 CONTROL OF PRODUCTION 11 NONCONFORMING MATERIAL CONTROL 13 WAREHOUSING AND DISTRIBUTION CONTROL 13 RECORDS 14 RETAINED SAMPLES 15 CUSTOMER COMPLAINTS 16 CUSTOMER RETURNS 16 AUDITS 17 CONTINUOUS IMPROVEMENT 17 BIBLIOGRAPHY 18 INTRODUCTION An essential element in cosmetics manufacturing is the establishment, implementation, and enforcement of good manufacturing practices (GMPs) that define control systems designed to assure product quality and consumer safety.

2 These GUIDELINES are intended as a model to assist cosmetics manufacturers, suppliers, and contractors in developing GMP programs which will ensure that products are prepared, packaged, stored, and distributed under controlled and sanitary conditions which prevent them from becoming contaminated or rendered injurious to health or unfit for their intended use. Note: These GUIDELINES do not apply to products which have been designated as drugs or pharmaceuticals by regulatory agencies. Two key elements should be considered essential to an effective GMP program: Provision of documented systems and procedures that govern the appropriate elements set forth in these GUIDELINES and any other requirements which may be needed due to local circumstances, laws, or regulations. Such documentation will help to ensure clear understanding, consistent performance, and long-term continuity.

3 Periodic audits to verify consistent compliance with GMP systems, to confirm that the systems remain adequate for provision of safe and effective COSMETIC products, and to highlight areas which may require improvement. Additional detailed guidance for developing GMP programs can be found in the publications cited in the Bibliography at the end of these GUIDELINES . QUALITY ASSURANCE It is vitally important to effective GMP that management establishes quality assurance systems which ensure the attainment and maintenance of quality requirements, and continuously drives plant-wide understanding of the principle that "quality is everyone s responsibility." Responsibility for managing the quality assurance systems should be assigned to a Quality group which is organizationally independent from other functions and which is suitably organized and staffed with trained personnel.

4 The responsibilities of the Quality group should embrace all activities concerned with attainment and proof of required quality, particularly: Maintenance and control of documented quality assurance systems, and performance of appropriate monitoring in order to ensure system compliance. Review and approval of specifications, manufacturing and control procedures, test methods, and all other documents which impact upon quality and GMP. Assurance of suitable inspection and testing to verify quality conformance. Quality disposition of raw materials, packaging materials, in-process materials, and finished products. Review of quality results, identification of problems, and pursuit of corrective action. Maintenance of quality records. PERSONNEL The following organizational and staffing measures will help to ensure GMP effectiveness: A specific committee or person should be assigned responsibility for overseeing plant-wide GMP compliance.

5 Responsibility for GMP compliance within each involved function should be assigned to appropriate management or supervisory personnel. An adequate number of personnel should be provided for the manufacture and control of COSMETIC products. They should have sufficient education/experience and training to ensure manufacture of acceptable and safe products. There should be an established program of ongoing training in all aspects of GMP for all personnel involved in the manufacturing and control of COSMETIC products and materials. It is particularly important to ensure, and continuously reinforce, plant-wide awareness of the need to maintain good personal hygiene practices when manufacturing and handling COSMETIC products and materials. Training in personal hygiene practices should include these key points: Personnel should maintain a high degree of personal cleanliness, wear clean outer garments, and if appropriate wear hair restraints and use clean gloves, wipers, or similar items when working with products and product contact surfaces.

6 No person with any health condition that might adversely affect products should have direct contact with raw materials, packaging, products, or product contact surfaces. Personnel should store personal belongings and eat, drink, or use tobacco only in designated areas. PLANT AND GROUNDS All plant areas and the immediate grounds should be kept clean, orderly, and in good repair. Buildings and work areas should be of suitable size and construction to facilitate adequate cleaning and maintenance and to ensure safe, effective operations. Plant areas should have adequate lighting, ventilation, and screened doors and windows. Steps should be taken to ensure adequate control of air flow, humidity, temperature, and dust wherever deemed necessary in order to prevent product contamination or degradation. Water and Plumbing Water that conforms to applicable drinking water standards should be supplied, under continuous positive pressure, by means of a plumbing system which is free of defects that could contribute to product contamination.

7 Drains should be of sufficient size to prevent clogging; if they are directly connected to a sewer, they should be equipped with an air-break or other mechanical device in order to prevent back-siphonage. Protection Against Contamination Measures should be taken to ensure that facilities are designed, located, and maintained so as to prevent products, raw materials, intermediates, and packaging from being contaminated with filth, microorganisms, or other extraneous matter. This may be accomplished by: Separation (by location, enclosure, partitioning, air flow, etc.) of such activities as receiving, storage, mixing and filling, packing and shipping, control and laboratory operations, and cleaning/sanitation of equipment and utensils. Design and layout of facilities, equipment, and systems for water storage and delivery in a manner that facilitates cleaning and sanitization.

8 Provision of appropriate programs for pest prevention and control. Effective housekeeping disciplines. Facilities for Personal Hygiene Adequate and readily accessible hygiene (particularly handwashing) facilities should be provided for all personnel who may handle unprotected COSMETIC products, raw materials, packaging, and product contact surfaces. Such facilities should ensure provision of: Water at a suitable temperature. Effective hand cleaning preparations. Sanitary towel service or suitable drying devices. Clearly-identified waste receptacles, constructed and maintained in a manner designed to promote personal hygiene and prevent product contamination. Prominent signs directing personnel to wash their hands before handling products, raw materials, packaging materials, or product contact surfaces. EQUIPMENT Equipment and utensils used in manufacturing , packaging, and handling COSMETIC products should be of suitable type, design, size, and accuracy for their intended use (mixing, weighing, measuring, testing, etc.)

9 They should be kept clean and orderly, and be properly maintained and calibrated. Design, Construction, and Installation Equipment should be designed, constructed, and installed in such a manner as to: Facilitate effective operation, cleaning, sanitization, adjustment, and maintenance. Assure reliability of controls and uniformity of production. Prevent introducing contaminants from prior and current operations into products. Surfaces that come into contact with products should not be reactive, additive, or absorptive so as to alter products. Substances used to facilitate the operation of equipment, such as lubricants and coolants, should not contact any product in such a way as to alter it. Cleaning/Sanitization and Maintenance Procedures for cleaning, sanitization, and maintenance of equipment and utensils should include responsibilities, frequencies, methods, protective measures, and requirements for maintaining suitable records.

10 Cleaning and sanitization of equipment and utensils should be carried out in a manner designed to prevent contamination of raw materials, packaging materials, or products. All cleaning compounds, sanitizing agents, and pesticide chemicals should be Prominently identified. Stored, handled, and used in a manner designed to prevent contamination of raw materials, packaging materials, in-process materials, or products. Used only in such a manner, and under such conditions, as will be safe and effective for their intended use. Calibration Mechanical, automatic, or electronic equipment should be routinely calibrated or checked in accordance with established programs and schedules. Computer systems used in compiling production and control records should be routinely checked to confirm correct operation. Access to such systems should be restricted to authorized personnel.