PHARMACEUTICAL PRODUCTS CONSULTING
Having the appropriate Quality Management System and complying with Good Manufacturing Practices requirements is a must for pharmaceutical and biologic companies before getting their products approved for use in humans. Unfortunately, being and staying in compliance with the applicable quality standards can be very challenging and costly process.
Global Regulatory Partners (GRP) Quality Team has the skills and required quality certifications to assist pharmaceutical and biologics companies install and maintain their quality management systems. GRP’s quality controls and quality assurance will allow companies to keep their products registered and sold in markets throughout the world.
Whether you are short on resources, short on time, or short on experience, you can count on GRP QA team to bridge the gaps and lay the foundation for your success. GRP QA team can perform for you the following types of quality audits if needed:
GAP Analysis Audits
Audits performed to assess the level of compliance of a pharmaceutical and biologic company to one or more of the following quality standards: Our Gap Analysis audits define current levels of compliance with all appropriate quality regulations, including FDA QSR, FDA GMP, ISO 13485 regulations, Japan PAL, EU regulations and Canadian Standards CMDR. The gap analysis is typically conducted before the implementation of a new quality system or before health authority or notified body audit.
Foreign Manufacturer Accreditation Audit (FMA)
Audits performed to help pharmaceutical and biologic companies prepare for the Japanese accreditation audit that need to be completed by PMDA (Japanese Health Authorities) before registration in Japan.
In Japan, Good Manufacturing Practice (GMP) for drugs is referred to as Japanese GMP, or J-GMP. Other Japan-specific pharmaceutical/drug quality standards include the following: Good Quality Practice (GQP), Good Vigilance Practice (GVP), Good Clinical Practice (GCP), and Good Post-marketing Study Practice (GPSP).
Full or Partial Internal Audits
Audits performed at pharmaceutical and biologic companies to provide an independent review of their full or partial quality system. These audits can also be focused on areas where internal audits cannot be conducted by in-house auditor due to possible conflict of interest.
Our team audits to applicable and appropriate standards, including:
- 21CFR part 11
- 21CFR part 211
- 21CFR part 212
- Good Manufacturing Practice (GMP)
- Good Laboratory Practice (GLP)
- Good Clinical Practice (GCP)
If you have been cited already, GRP can help you get back on track. If you haven’t been cited but have concerns about potential issues anyway, we can steer you in the right direction. Our areas of expertise include:
- Risk management
- Compliance monitoring
- Corrective and preventive action (CAPA)
- Complaint management
- Stability support services
- Vendor management
Contact us today to learn more about how we can assist your company with quality control, quality assurance and quality management systems and compliance.