QPs – Critical Regulatory Role for Biopharmaceutical Manufacturing.

The demand for Qualified Persons (QPs) continues to rise within the biopharmaceutical industry but availability of suitably experienced personnel can be a challenge for companies.

What is required of QPs in the industry?

• Ensure that all products are manufactured in compliance with the EU marketing and manufacturing authorizations and with cGMP compliance.
• Perform duties in line with the Code of Practice for qualified persons in the pharmaceutical industry.
• Ensure that all principal manufacturing, packaging and testing processes have been validated.
• Assure the development, approval and implementation of standards, procedures and systems to maintain an effective and compliant quality management system.
• Performing deviation investigation, root cause analysis and CAPA identification to promote continuous improvement.

Peritus Regulatory Compliance team have Qualified Persons under permanent provisions who have:

• Performed manufacturing audits to FDA CRF 210/211 and EU GMP regulations
• Provided manufacturing oversight for US / EU Clinical Studies
• Audited API and finished product manufacturers globally
• Performed GMP gap analysis for US monograph products
• Participated in FDA and MHRA site inspections

Here is an example of how one of QP’s responsibilities working with a biologics development company. The QP was responsible for the oversight of the quality management system within the company, to support the clinical development programme, to ensure compliance to GCP, GMP and GAMP (GxPs). Main duties include:

• Managing the supply of APIs and investigational medicinal products
• Management of the document control group within the company
• Responsible for the internal and external (vendor) audit schedule, conducting audits of key service providers
• Final verification and approval of preclinical and clinical data in support of the company’s clinical development programme
• Quality assurance representative for computer systems validation
• Computer systems validation and undertake clinical audits of Clinical Study Reports and Trial Master Files

Peritus Regulatory has a thorough understanding of demands of companies small and large with respect to QP services. Our services can be for short-term projects, immediate project deadlines support, product audits, addressing compliance issues, work-force shortages – allowing you to manage your budgets and accessing specialist services as and when required.