Quality control is a way of life at Partners In Care.
Automobile collectors know that there was a vast difference between the 1985 Yugo and the 1985 Cadillac Convertible. They are both cars and they both met the quality control standards in their respective factories, however there is a difference in the final quality of each car. The 1985 Yugo has been called the worst car ever built. The durability, comparable quality, and performance of each car was vastly different.
Cooks and connoisseurs of apple pie know there is a wide range of differences in pies. From a gourmet pie at Bones restaurant in Atlanta to a slab of pie at a local café, both are apple pies but there are differences in quality, presentation and price. I don’t remember having a bad apple pie only ok, good, very good, excellent, and exquisite. The Peter Paul and Mary’s song Inside tells about a pie eating contest and what makes a difference in apple pies:
- Store bought crust or homemade crust
- Canned filling or fresh apples
- Sugar or brown sugar
- Commercial spice mix or a custom mix of spices
- The most important part is the cooks expertise and dedication to quality
Compounded products, like cars and apple pies, can have differences in quality. The first step in a high quality compound is the supplier of our chemicals. Our supplier’s first choice for sources of chemicals are manufactures in the United States or Europe rather the Asia. The choice of manufactures is based on good manufacturing practices (GMP) and FDA registered facilities with U. S. Pharmacopeia
(USP) grade chemicals a priority. Each package received is checked for damage, avoiding the possibility of contaminated chemicals. The quality control department then:
- Verifies the manufactures original certificate of analysis (CofA)
- Check the expiration date specifications
- Verifies the chemicals match their description and solubility
- Plus numerous other tests to verify the chemical is what it is labeled as
After verification of the chemicals quality, they are then moved to the production department. Our chemical suppliers are a registered FDA repacker following cGMP guidelines
and over 60 standard operating procedures (SOPs). Production specific SOPs include:
- Temperature and light sensitive products
- Nitrogen repacking
Shipping is done in a manner to protect to protect the chemicals from temperature changes or extremes and humidity. Hazardous chemicals are always shipped separately to avoid any possibility of contaminating the other chemicals in the same order.
When a chemical is received at Partners In Care, the order sheet is checked against the packing slip to ascertain the correct chemical is received. The chemicals received are then verified against the packing slip. Verification that the certificate of analysis (C of A) has arrived for each chemical and has been checked and filed.
The chemical is then entered into the inventory of the pharmacy and a barcode is printed and attached to the product. The barcode contains the following information: product name, lot number, manufacture, expiration date, purity, supplier, product size and cost. Temperature and humidity are controlled in acceptable ranges. Chemicals that require refrigeration are stored under refrigeration and temperatures are checked and recorded daily.
Chemicals used in sterile compounding are segregated from the rest of the chemical inventory.
There is a certificate of analysis (C of A) on hand for each lot of each chemical that is used in any product. Each item that is used in a formula is electronically scanned and must match the chemical on the printed log sheet, its lot number and expiration date before the technician can proceed to the next step. To ensure that each active ingredient is accurately measure and recorded, the pharmacy’s electronic balances are connected to the computer and the scale weight and percent off is recorded in the log of each product. A lot number is assigned to each log sheet of each product prepared in the pharmacy. See an example
of such a log, also note that the lot number of each chemical is scanned and recorded. The formulas lot number is recorded on each prescription dispensed, in case there is ever any need for patients follow up on a particular lot.
After a product (e.g. capsules or tablets) have been compounded, it is first visually examined for uniformity of color and mixing. Next the product is weighed to assure it matches the weight in the log for that batch. After the total weight of the product is verified, the individual capsules, tablets, demi's or troches are weighed to verify product uniformity. Products undergo random testing for potency. A failure in any of these steps results in product destruction of that lot.
Like an apple pie, the selection of each ingredient in a compounded medication has a significant difference on quality and effectiveness. A study by Gus Bassani, PharmD published in Professional Compounding Centers of America's Apothaagram, June 2008, shows the importance of selection of a particular wetting agent can have on the efficacy of a transdermal medication.
Sterile compounding is an area which Partners In Care's USP 797 Clean Room standards excels. Partners in Care’s clean room meets USP standards and the airflow is certified. All work is done in a class 100-work environment. There are logs of the cleaning schedules of the clean room and the proper rotation of the cleaning agents to prevent bacterial and fungal resistance. Air particle tests and surface tests are done on a regular basis. Sharlaine Johnsa, CPT and Pam Haynes, CPT were trained and certified in Sterile Compounding at Professional Compounding Centers of America (PCCA). Gowning requirements are fully met in a separate ante room i.e. hair covers, shoe covers, disposable jump suits, face mask and sanitized gloves.
After a batch of sterile product (e.g. injectable solutions or injectable suspension) has been compounded and brought out of the clean room, each vial is visually inspected (i.e. solutions are checked for foreign material and suspensions are checked for clumping and even dispersion on shaking). The integrity of filters used in preparation of solutions is bubble tested. A failure at this point requires the pharmacist to decide to refilter or discard the batch. Next each vial is weighed to assure uniform filling of each vial. The sterile products are then quarantined and a random sample is sent to an outside laboratory for testing. A product is only removed from quarantine for sale after the lab report is on file in the pharmacy.
The above procedures are only a representation of some of the detailed steps we take to produce a quality compounded medication.
Overview of Chapter <797> "Pharmaceutical Compounding - Sterile Preparations": The Potential Impact for Compounding Pharmacists
Author(s):Cutter, Rahe, Hank
The author discusses the new regulations, enforceable at both the state and federal levels, from the US Pharmacopeia Convention (Chapter <797>) regarding the compounding of sterile preparations. The scope, major implications, preparations, general description of regulation contents and acceptable environments are covered. The main focus of the discussion centers on microbial contamination risk levels; responsibilities of compounding personnel; facilities and equipment; cleanrooms; barrier isolators; verification of compounding accuracy and sterilization; sterilization methods; personnel training and evaluation in aseptic manipulation skills; maintenance of product quality and control after the compounded sterile preparation leaves the pharmacy; packaging, handling and transportation; use and storage; redispensed compounded sterile products; patient monitoring and adverse events reporting and suggested standard operating procedures.
IJPC Vol. 8 No. 2 March April 2004 - Click here to request a printed copy of this article