Every batch of raw material or herbs that we use is tested for quality as required by the Regulatory Authorities. This is performed either in-house or using TGA Approved Contract Testing Laboratories adopting test methods these include Thin Layer Chromatography (TLC) which provides positive identification of a herb, and High Performance Liquid Chromatography (HPLC) which provides evidence of the actives present in a manner approved by the various Pharmacopeias, accepted by then TGA.

We use the cold percolation process for the extraction of our herbs and avoid heating in all stages of production. The use of heat can speed up production of herbal extraction, but it does reduce the level of the actives, enzymes and nutrients in them, which is why we do not use it.

All the manufacturing processes are performed inside our Clean Rooms under GMP conditions and all products manufactured undergo rigorous Finished Product Testing to meet the specifications laid down by regulators.

Our Quality Documentation procedure allows for complete traceability of all products, processes, equipment including, raw materials, finished products, and all aspects of the manufacturing processes.

Our Quality Systems also address investigations on Variances and Out-of-Specification test results and aim at Corrective and Preventive Actions (CAPA). This is the secret of our success in manufacturing Quality Products consistently and meeting Customer Satisfaction.


Example: 1: The following scan shows the comparison between one of our incoming raw materials Panax ginseng being tested against out standard Panax ginseng reference sample. From the two TLC fingerprints, we can easily identify that the incoming raw material of Panax ginseng compares to the reference sample.

Example 2: The following TLC scan shows the fingerprint of the herb Echinacea purpurea tested against authenticated reference sample of Echinacea purpurea and internal standards caffeic and chlorogenic acids. From the TLC profiles of the test material and the reference sample, the identity of the raw material can be confirmed. This method eliminates the risk of using wrong herbs and can identify the adulteration of herbs by some suppliers.

In the above TLC scan, lane 1 is standards of Chlorogenic and caffeic acids, lane 2 and 4 are reference standard extracts of Echinacea purpurea and lane 3 and 5 are extracts of Echinacea purpurea sample to be identified.

Additionally, all raw materials undergo microbiological testing for Total Aerobic Microbial Count, Yeast and Mold, Salmonella spp. and E.coli to determine the microbial bioburden level. Here again, we follow the specification laid down by the regulators of medicinal products (TGA) and hence, only the best herb is selected for further processing.

Batch Processing and Traceability: All manufacturing processes at PPC are governed by written Standard Operating Procedures (SOP’s) and Batch Processing documents. This is to ensure that the Product is manufactured to specifications, consistency in quality, batch reproducibility and traceability. In fact, we do have a SOP on how to write SOP’s and how to update SOP’s. All manufacturing operations are traceable by their Batch Number to their batch documents, dispensing records of raw materials, equipment used in the operation, the operator who performed any part of the manufacturing process, the cleaning status of the equipment used, in-process quality results, reconciliation of the yield of the product, test results etc. In short, all aspects of the manufacturing process and Quality Control are recorded and traceable. We also retain retention samples of all raw materials and finished product until the expiry of the product and the batch documents are held for 5 years from the date of manufacture of a product.

Internal Audit/Self Inspection: PPC believes that Quality Control and Quality Assurance are the secrets of our success. In order to maintain our high standards, we conduct Internal Audits/Self Inspections of all aspects of our Manufacturing and Quality Systems on a regular basis. This is performed either by the Quality Assurance Manager of PPC or by External Consultants. This helps us to correct ourselves if we had done any mistakes and constantly improve our Quality Standards. These Internal Audits/Self-Inspections are in addition to the regular GMP audits performed on us by the different Regulatory bodies like the TGA, NASAA,BFA and OGA.