Quality Assurance

Our focus is compounding with bioidentical hormones. Compounding is done exclusively and daily by laboratory staff. Laboratory staff consists of pharmacists, technicians, and lab support personnel. All technicians are required to complete national certification. All staff participates in a multi-faceted training program, which includes competency and completion of training documentation.

Compounding equipment is required in any pharmacy; however, our equipment far exceeds the minimum. We use a variety of pharmacy tools to assist us in ensuring the accuracy and uniformity of each compound. These include electronic balances, encapsulation devices, electronic mortar and pestles, and pipettes. All equipment is on a routine maintenance and cleaning schedule. Evaluation of balance accuracy is done daily by staff and regularly by an independent ISO 9002 and Guide 25 Registered Scale Company.

Our ISO Class 7 clean-room encloses an ISO Class 5 Laminar Air Flow Hood. Our sterile processes and quality assurance procedures meet, or exceed USP Chapter <797> standards specific to high-risk level compounded sterile products.

Women’s International Pharmacy orders pharmaceutical grade materials from several long-standing, reputable chemical suppliers. Each of the active ingredients that we purchase is delivered with a Certificate of Analysis to verify the identity and the quality. We independently test some of our ingredients randomly.

To ensure the high quality of our compounds and the safety of our workplace, we have established lab safety and hygiene policies. Our lab staff wear personal protective gear (scrub attire, masks and gloves), and utilizes powder containment (ventilation hoods) and sanitizing equipment. Our compounding area is segregated and operates on a self-contained ventilation system. Routine cleaning procedures are in place for the preparation of all compounds and for maintaining the lab equipment. Additionally, we are sympathetic toward environmental issues. We use solutions of ethyl alcohol to clean in our lab to avoid exposure of our preparations to chemicals in cleaning agents, dispose of all of our ingredient waste at EPA approved facilities, and participate in recycling programs where available.

Our compounding procedures are carefully documented and each compound goes through a comprehensive series of checks. Compounding pharmacists verify formula calculations, ingredients and the final compounded prescriptions. They also supervise the compounding technicians and verify adherence to procedures. Lot numbers and computerized records for each compound are maintained and procedures to verify final weights of dosage forms are documented. Our procedures enable us to track prescriptions back to the ingredients used to make each preparation.

The monitoring of our quality control measures is accomplished through a variety of methods. We have staff who meet regularly to review processes, evaluate supplies and monitor overall quality. Additionally, we randomly select finished compounds for analysis by an independent laboratory to verify our procedures.

We are committed to the future of compounding. We have pledged our support to numerous issues relating to the importance of individually tailored medications. Additionally, we belong to several organizations committed to professional compounding: 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.

Finally, we hold licenses in each state, as they require.

If we can be of any further assistance, please contact us.

Women’s International Pharmacy, Inc.
Toll Free Phone: 800. 279. 5708 ~ Toll Free Fax: 800. 279. 8011 ~ Email: info@womensinternational.com