Quality Management & Compliance auditing
PharmaConsult will provide services across a company’s life cycle from helping emerging company’s set-up quality systems and generate SOPs to assisting mature companies review batch records, audit suppliers and manage consent decrees.
When a biopharmaceutical, medical device or diagnostics company needs a QA consultant, it’s usually for one of two reasons. Either they need someone who can provide high-level leadership and guidance in establishing the company’s QA practices from the ground up or they need someone who can step in to supplement existing staff during busy times. We address both types of needs. Our roster of consultants ranges from strong mid-level talent, to some of the highest skilled, senior-level talent in the industry. Our goal: match your needs with the right person for the job.
We'll resolve issues with specific difficulties and provide you with an assessment of compliance with the appropriate regulation EU GMP Guidelines Vol 4, ISO 9001, or ISO 13485 standards.
a) We will also assist in the Quality systems management;
The GMPs for the manufacture of Active Pharmaceutical Ingredients (APIs) and Final Drug Products require a full system of Standard Operating Procedures (SOPs), procedures (e.g., receipt, sampling, and deviation investigation), and processes (batch records). We can help you create the systems you need for:
- Quality Management Systems,
- Batch Disposition & Deviation Resolution
- Facilities and Equipment Management
- Laboratory Information Management systems,
- Materials Receipt, Sampling, and Acceptance
- Product Complaint Management
- Supply Chain Management
- Packaging and Labelling and
b) PharmaConsult Auditing services will;
- Examine your manufacturing processes and integrity of data collection systems.
- We'll carry out GMP reviews of manufacturing facilities and quality management systems
- We'll audit your suppliers and contractors for compliance with GMP, GLP or other standards
- We'll work with your QPs and other in-house QA experts to improve presentation of facility and systems for Inspectors
- We'll prepare response documents or appeals on your behalf
The evaluation of the risk to quality will be based on scientific knowledge and ultimately link to the protection of the patient (ICHQ9) and the Quality management systems (ICH Q10)
c) QP Quality release certification
We have a comprehensive network of experienced QP’s in UK and EU so we can supply GMP compliance of materials and finished product to allow final QP assessment and release certification to be made in the intended market.