Quality Assurance
 Women’s International Pharmacy is committed to superior custom-compounded bioidentical hormones for both men and women. Since 1985, we have filled thousands of prescriptions with precision and unwavering quality. We employ good compounding practices as found in the United States Pharmacopeia (USP) Chapter 795 and Pharmaceutical Compounding-Non-Sterile Preparations.
Women’s International Pharmacy maintains stringent compounding proficiency and quality assurance standards. Compounding is completed by skilled pharmacists as well as nationally certified technicians. All staff members complete regular training programs and competency assessments as required by state regulations and federal guidelines.
Specially Designed Facilities and Equipment Ensure Quality
Women’s International Pharmacy has specially designed facilities to ensure the quality of our compounded medications. We meet all compendia guidelines for personnel and testing products. Our lab staff regularly use personal protective gear (masks and gloves), as well as powder containment (ventilation hoods) and sanitized equipment. Our compounding area is segregated and operates on a self-contained ventilation system. Every piece of equipment is expertly maintained. Cleaning and maintenance are documented according to USP requirements.
To ensure accuracy and uniformity of compounded medications, Women’s International Pharmacy utilizes equipment that meets quality standards, including electronic balances, encapsulation equipment, and electronic mortars and pestles. Equipment is evaluated for accuracy on a daily basis. An independent ISO 9002 and Guide 25 Registered Scale Company conduct regular external evaluation of our balances.
Sterile compounds dispensed by Women’s International Pharmacy are prepared in our affiliate and separately licensed clean room lab. The clean room is an ISO Class 7 room that encloses an ISO Class 5 clean bench. The clean room is independently tested on a biannual basis to ensure sterility standards are maintained. The sterile processes and quality assurance procedures meet or exceed USP Chapter 797 standards specific to high-risk compounded sterile products.
Only High-Grade Materials Used
Women’s International Pharmacy uses only high-grade materials supplied from reputable sources. These materials also meet official compendium requirements. Each active ingredient is delivered with a certificate of analysis verifying the identity and quality of the pure drug powders. Independent testing of ingredients by an analytical laboratory may also be done. All waste is disposed of at Environmental Protection Agency (EPA) approved facilities.
Procedural Standards
Procedures for compounding are thoroughly reviewed prior to implementation. These procedures are then validated to ensure that the compounded medications are of the appropriate strength, quality, and purity. Outside analytical laboratories are routinely used to validate our processes.
Each individual compound is prepared according to a standard procedure. Compounding pharmacists verify formula calculations, ingredients and the final compounded prescriptions. The finished compound is also verified for appearance, quality, quantity, and standardization of dosing. Every prescription may be tracked back to the ingredients used to make the compound via lot numbers and electronic records.
Continuous Quality Improvement
At Women’s International Pharmacy, maintaining the quality of our preparations is of paramount importance. Therefore, a continuous quality improvement process is employed. Our entire staff takes an active role in our quality review and improvement process.
Professional Affiliations
Women’s International Pharmacy staff members belong to several organizations involved with professional pharmacy compounding, including the International Academy of Compounding Pharmacists (IACP), American College of Apothecaries (ACA), United States Pharmacopoeia (USP), the National Association of Community Pharmacists (NACP), and the American Pharmacist’s Association (APhA). On a local level, we maintain relationships with faculties and students at the University of Wisconsin School of Pharmacy, Midwestern University College of Pharmacy, and our state associations, which give us valuable resources for compounding issues. |
