Good Manufacturing Practice Consulting Services

Adhering to Good Manufacturing Practice (GMP) is more than a compliance requirement for pharmaceutical, biotech and medical device companies. It is a fundamental commitment to patient safety and brand integrity.

FDA Quality and Regulatory Consultants (FDAQRC) offers expert GMP consulting services to help you with all your compliance needs.

The Five Pillars of Good Manufacturing Practice

Observing the five essential pillars of GMP helps achieve and maintain proper GMP compliance:

  1. People: Ensure all your employees are qualified and thoroughly trained for their specific duties. Clearly defining roles and responsibilities helps every team member understand their contribution in maintaining quality and safety.
  2. Premises: You and your team must maintain a suitable, clean manufacturing environment to promote product quality. This effort also includes adhering to proper equipment maintenance and calibration.
  3. Processes: You must clearly define your manufacturing processes, scientifically validate them and consistently follow them to ensure uniformity and quality across batches.
  4. Products: All raw materials, components and finished products must have clear, predefined specifications. You must rigorously test them for correct handling and storage to preserve their identity, purity and quality.
  5. Procedures: Clearly document all critical activities affecting product quality in written Standard Operating Procedures (SOPs). Relevant employees must have access to these procedures and follow them strictly to promote operational consistency.

Common GMP Compliance Challenges

Pharmaceutical, biotech and medical device industry leaders often face challenges that compromise compliance and product quality. These include:

  • People and culture: A culture driven by deadlines over quality can lead to a fear of reporting errors, while training may not translate into practice.
  • Premises and equipment: Business pressures often lead to deferred maintenance and calibration, increasing the potential for risks in the manufacturing environment.
  • Processes and procedures: The rush to market could result in shortcuts in process validation and surface-level Corrective and Preventive Actions (CAPA) investigations that fail to find the true root cause behind problems.
  • Products and materials: Managing a complex global supply chain makes it challenging to verify the quality of all raw materials and cost pressures may tempt companies to use less reliable suppliers.

Your Bridge to GMP Excellence

FDAQRC provides specialized expertise to help your business overcome the challenges of GMP compliance.

Quality Assurance for GMP Compliance

This foundational service supports all five pillars. Our experts establish the quality processes that keep your products aligned with the latest requirements.

  • GMP audits: We conduct thorough internal and external audits to identify compliance gaps in your premises, processes and procedures and recommend actionable improvements.
  • Quality management system (QMS) implementation: Our team helps you develop, implement and manage a QMS that aligns with regulations and drives process documentation, control and effectiveness.
  • Qualified person (QP) support: We offer QP support for companies navigating international regulations to facilitate product adherence to the stringent requirements for release in different markets.

GMP Remediation Services for Warning Letters

When you receive an FDA 483 or warning letter, we assist you in identifying the root cause of noncompliance. Our experts implement sustainable corrective actions and advise on appropriate warning letter response and review.

Good Manufacturing Practice Audit Readiness

Our audit readiness program prepares your facility, documentation and personnel for an FDA audit. We conduct mock inspections and comprehensive gap analyses to verify your processes, documentation and team readiness.

Qualification and Validation Services

Our services verify that your critical assets meet predefined specifications and requirements to maintain compliance, promote consistent product quality and minimize operational risk.

Why Choose FDAQRC for GMP Consulting Services

With a global consultant network and years of GxP consulting experience, we can help you meet all your GMP needs. Our experts scrutinize the fine details to prepare you for FDA GMP inspections.

From anticipating future challenges and providing strategic advice to offering a high-touch partnership, FDAQRC helps you strengthen every pillar of your quality system and drive full compliance with FDA and WHO GMP standards.

Request a GMP Compliance Consultation

FDAQRC is ready to assist with FDA inspections, warning letter remediation and ongoing compliance support. Contact us online today to discuss your needs with a GMP consultant.

Request a Consultation