GMP Storage
GMP storage and handling play a crucial role in maintaining the integrity of products and ensuring regulatory compliance. It is critical for pharmaceuticals, food and cosmetics where compliance with cGMP standards is required to ensure product safety, efficacy and quality.
All material that arrives on our site is receipted, stored and managed following TGA certified GMP processes. Our qualified storage chambers meet cGMP requirements for segregation and labelling of products, to prevent cross-contamination and ensure traceability across the products life cycle, with appropriate documentation and record-keeping in place.
Our GMP Storage Facilities
GMP controlled storage conditions offered by Pharmsky include:
- -20°C ± 5°C
- 5°C ± 3°C
- 25°C ± 2°C / 60 ± 5% RH
- 40°C ± 2°C / 75 ± 5% RH
We also have an ambient/uncontrolled temperature GMP storage area. Our facilities support a range of pharmaceutical cold storage and temperature-controlled pharmaceutical storage requirements, with conditions selected according to the characteristics and stability requirements of each product or material.
GMP Storage Solutions
An extensive range of products can be stored on-site including; stability samples, raw materials/excipients, API, finished products, in-process products, liquid form samples/materials, solid form samples/materials, and scheduled 8 and 9 substances.
Pharmaceutical Storage Services
PharmSky provides GMP storage services for a range of pharmaceutical materials and products. Our facilities can also support clinical trial storage, controlled drug storage and GMP warehousing requirements.
For organisations seeking GMP compliant storage in Australia, PharmSky offers TGA-certified processes, qualified storage chambers and appropriate documentation and record-keeping.
Compliance with GMP Storage Requirements
Pharmsky has a TGA-certified analytical laboratory, strictly following all the GMP guidelines.
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Frequently Asked Questions
Temperature and humidity controlled storage and testing shearing to TGA certified GMP storage requirements.
Short shelf life products, where product is unstable at room temperature.
