Quality Control
We are a compounding only pharmacy which means we specialise solely in compounding. We do so in order to concentrate our attention on compounding and thus not be distracted by traditional retail pharmacy. A primary concern and focus for us is quality control in order to provide pharmaceutical quality medications. This involves being equipped with a modern state of the art laboratory with modern pharmaceutical compounding equipment in conjunction with tight quality control procedures.
Complementary Compounding Services has moved into our new purpose built world class State-Of-The-Art multi-clean room facility. We have separate clean rooms catering for Bio-identical Hormones and one for nutraceutical products both separated by an ante room/air lock. In addition there is an ante room and adjacent sterile room for the production of sterile dose forms. Each room is separated which ensures that no cross contamination of products occurs during the compounding process. In addition each of the clean rooms and sterile room is supplied by its own individual isolated filtered air supply to avoid air contaminants from other rooms or the outside environment entering even through recirculated air via the air conditioning system. Each room is also maintained under positive pressure to avoid contaminants entering the room with the exception of the HRT Lab which is maintained under a negative pressure which prevents hormone dust from escaping from the room. Each room is constantly monitored and maintained at a constant pressure, temperature and humidity in order to maintain the maximum stability of all raw ingredients.
Our Clean rooms are built to the highest specification from stainless steel bench tops, epoxy coated walls, door seals, laboratory lighting, being air tight, etc, etc which complies with the TGA’s PIC/S (Pharmaceutical Inspection Convention/Scheme) standards.
Our specialized compounding clean rooms are exceptionally clean environments. Staff entering these rooms must be appropriately gowned including face masks, gloves, shoe covers and hair nets. We also have a strict daily cleaning procedure to ensure it is maintained so.
Our sterile room is an ISO Class 7 room with an adjacent ISO Class 8 ante room. We have a GERMFREE ISO Class 5 sterile laminar flow Barrier Isolator for the production of sterile injections in the ISO 7 sterile room which meets TGA standards for sterile products.
Our clean rooms are each equipped with a Gelaire isolation cabinet which contains a HEPTA filter for the removal of airborne particles down to 0.3 microns. This enables us to produce dust and particulate free capsules, creams and lozenges and also prevent cross contamination of powders.
Our laboratory will only use the purist pharmaceutical grade raw materials available. Most ingredients used in our laboratory are obtained from the same suppliers that supply the pharmaceutical industry and each ingredient obtained is accompanied with a certificate of analysis to prove that it was analysed prior to purchase and that its quality was found to comply with pharmaceutical grade standards. No raw ingredients are accepted by us unless its analysis shows it to be of pharmaceutical grade.
Our laboratory is equipped with several NATA approved computerized electronic analytical balances that are capable of measuring down to the nearest milligram. This ensures that all the raw ingredients used to make your medication are accurately weighed out. The weight of each ingredient used to produce your medication is then recorded for future reference.
Once accurately weighed all ingredients used to produce creams are then mixed using our pharmaceutical grade computerised cream homogeniser. This specialised mixer is used for the production of pharmaceutical grade creams with a consistent and uniform distribution of medication throughout the entire cream without any “empty spots” or “dense spots” that can occur with other types of mixers, or if mixed by hand.
All accurately weighed powders used to make capsules are blended by our Turbula Shaker-Mixer. This mixer utilises three dimensional reverse kinematics to blend any combination of powders, of various particle sizes, into a homogenous powdered mixture of uniform consistency. It does so without the generation of any heat thus protecting all ingredients for heat decomposition which is a major problem with blade type blenders. This type of mixer is currently considered one of the most effective mixers available by the pharmaceutical industry and is considered essential for accurately mixing powders especially those containing low doses of medication such as thyroid hormones.
Once all powders are mixed appropriately they are then encapsulated using one of our pharmaceutical grade capsule machines which are GMP, USP and BP compliant capable of filling powder weights within 1-3% variation. We have an automated electronic capsule counter to count capsules to ensure the number of capsules packaged is accurate.
Our laboratory is also equipped with a 4 stage reverse osmosis water purifier ensuring all preparations which contain water are contaminant free. We test the water regularly to ensure it meets pharmaceutical standards.
Standard Operating Procedures (SOPs) have been developed for every aspect of preparing your medication. From how to effectively clean the glassware used to produce your medication, lab cleaning schedules, gowning and personal hygene of lab staff, allowing new batches of raw ingredients to be used based on their certificate of analysis, checking our packaging to ensure it meets our high standards, etc, etc. This in combination with several checking procedures ensures every step in the production process is tightly controlled and monitored so there is little room for human error.
Our laboratory also uses specialised compounding software which allows us to deligate lot numbers to every item produced by our laboratory. These lot numbers are then matched to a unique production record for every product made in our laboratory so we can check (at any time) to see exactly what ingredients went into your medication and exactly how much of each ingredient (to the nearest milligram). The lot number of all raw ingredients used to make the final product and their used by dates are also recorded which enables us to double check their corresponding certificate of analysis and track batches of raw ingredients if need be for situations such as recalls. This record keeping process allows us to double check every product in order to ensure they all meet our high standards and to minimise any human error.
Finally the training and experience of the compounding pharmacist is also paramount to be able to competently supply pharmaceutical quality products. Our chief compounding pharmacist, Dr Michael Serafin, is a highly qualified compounding chemist with a Ph.D. in Pharmaceutical Chemistry from Sydney University. He has been involved with compounding since mid 1990′s and previously having worked for Sydney University teaching compounding theory and practice to pharmacy students while being involved with pharmaceutical research and development. His extensive experience and expertise ensures the highest quality of our formulas and products supplied by our laboratory.
The use of sophisticated NATA approved compounding equipment in a clean, environment controlled laboratory ensures the highest standards are maintained resulting with high quality products.
By adhering to set protocols and many regulations you can be assured of the quality of medication produced by Complementary Compounding Services. If you are currently obtaining your compounded medication elsewhere you should check to see if they too full fill this quality checklist.
When chosing which compounding pharmacy you should trust to prepare your medication you should consider all the factors mentioned above.
