In the pharmaceutical and healthcare industries, organisations stake their credibility and reputation on their individual products, which is why a consistent level of quality and stringent control procedures are vital to any developing production operation.
Here at Acumentia, our technical consultants make use of their vast experience to guide you through the vast array of guidelines, legislations and regulations that currently govern the international pharmaceutical production and biopharmaceutical industries. Though the majority of our experience lies in working with API development, we are also fully qualified to advise on a range of issues including cGLP, cGCP, and cGMP regulations.
We specialise in transforming an organisation’s in-house quality protocols through in-depth analysis and thorough revision; we closely examine every aspect of your production operation in order to identify areas that can be refined or made more efficient, ultimately improving your bottom line.
Our experience encompasses:
- Standard operating procedure (SOPs)
- Manufacturing record review
- Validation of equipment, facility and utilities
- Validation of procedures and cleaning validations
- Software (e.g. LIMS) validation
- Study protocols and reports
- Preparation for regulatory inspections
- Training record reviews
- Clinical study risk assessment
- Gap analysis and excursion management
- Deviation management
- Corrective and preventive actions
- Change control system
Our range of audits includes:
- Clinical site audits
- Vendor audits
- Laboratory audits
- Data management audits
- Quality system audits