Having previously been involved in the pharmaceutical industry for over 20 years we understand the importance of quality control to ensure consistent high quality products are supplied by PLC. 

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Private Label Cosmeceuticals (PLC) operates according to ISO 22716 QC standards using ISO 22716 approved Standard Operating Procedures (SOP’s) which regulate every aspect of business operation. We have specific SOPS which address:

 

(1) Control of Documents

(2) Control of Records

(3) Training

(4) Personal Hygiene

(5) Premises

(6) Pest management

(7) Equipment

(8) Purchasing

(9) Storage

(10) Production

(11) Finished Product

(12) Management Reviews

(13) Preventing Cross Contamination

(14) Drug Free Policy

(15) Quality Control

(16) Waste

(17) Complaints and Recall

(18) Internal Audits

(19) Batch Release and Records

(20) Sampling

 

Of particular interest to our clients our Batch Release and Records SOP addresses a number of procedures, some of interest include:

 

• assigning traceable unique batch numbers to every batch which is recorded on the Batch Processing Records which are held in records for 2 years according to our Control of Documents SOP’s.

• ensuring the calculations for the amounts of raw ingredients to be used on the Batch Processing Records are correct and raw ingredients are used within their expiry dates before production.

• Ensures the correct amounts of raw ingredients weighed are within acceptable target range (<2% error) during production.

• Post production it addresses any QC testing required which always involves pH and visual testing/inspection. Batches exceeding a predetermined batch size also undergo microbial testing and viscosity testing.

 

NOTE: We do not produce large batches and hold in stock in anticipation of future orders. All batches are made to order to ensure everything is made fresh to maximize its potency and shelf life. By only manufacturing to order allows us to customize scents, packaging, etc that would otherwise be impossible if batching for future orders was undertaken - which is common practice in this industry.

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Our Complaints and Recall SOP’s outlines procedures for any potential voluntary recalls in the unlikely event of:

• Customer complaint

• Detection of quality and safety failure after release

• Resulting from ongoing stability testing failures

• Result of an inspection

• Tampering

• Adverse event reporting

 

Our traceable unique batch numbers allows affected batches to be easily identified and recalled according to our Recall SOP’s.

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Our facility on the Gold Coast was built to GMP standards and maintained according to our Premises SOP to ensure an aseptic clean and hygienic environment is maintained to help ensure the quality of our products.

 

In addition to our ISO approved SOP’s we also ensure all ingredients used in our products are purchased from reputable industry suppliers with a proven track record and comply with the TGA’s Poisons Standard and are also permitted for use via The Australian Industrial Chemical Introduction Scheme (AICIS). We currently hold registration with the AICIS. Raw ingredients are stored in temperature controlled environment to ensure their stability is not compromised by excess heat or humidity.

 

As cosmetics fall under the pre-packaged goods category via The National Measurement Institute (NMI) whom regulate the quantity of packaged goods sold by measure equals that on the label. At PLC we use the Average System where no pre-packaged article can have a shortfall greater than 5% of the stated quantity to ensure we comply with NMI regulations.

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Our formulation Chemist has a PhD in Pharmaceutical Chemistry and is a member of The Australian Society of Cosmetic Chemists with over 25 years experience in formulating for the cosmetic and pharmaceutical industries ensuring the high standard of our formulations.

 

By adhering to ISO standards and other Industry guidelines PLC is confident that the high quality products we supply will exceed consumer expectation and help protect the reputation of partners that use our products.