Pharmaceutical Inspection Co-operation Scheme (PIC/S) Certification
Simplifying Your PIC/S GMP Compliance Journey
PIC/S Support Services for Global GMP Compliance
As global pharmaceutical regulations evolve, achieving compliance with the Pharmaceutical Inspection Co-operation Scheme (PIC/S) Good Manufacturing Practice (GMP) standards is crucial for organizations aiming for international market access and regulatory trust.
Zenovel offers assistance to manufacturers in aligning their quality systems with these globally harmonized GMP standards through strategic consulting and practical implementation support.
- Structured Approach
- Phase 1: Assessment & Planning:
Zenovel’s experts perform a gap analysis to assess your existing systems—such as Quality Management System, facilities, equipment, and documentation—against the PIC/S GMP Guide, and subsequently create a prioritized action plan to rectify identified deficiencies.
- Phase 2: System Development & Upgradation:
We help improve your Pharmaceutical Quality System (PQS) to comply with PIC/S standards, focusing on quality assurance, quality control, risk management, and advising on facility and equipment upgrades.
- Phase 3: Team Qualification & Culture Building:
Zenovel offers specialized training programs aimed at helping personnel understand and comply with PIC/S requirements, promoting a lasting culture of quality.
- Phase 4: Pre-Inspection Readiness:
We perform mock inspections to simulate the audit process, identify hidden shortcomings, train staff for confident responses, and ensure meticulous organization of records for official inspections.
- Our Audit Framework
To support these above steps, we offer range of PIC/S GMP Consulting Services for you:
1. PIC/S GMP Compliance Strategy
We develop customized compliance roadmaps aligned with global regulatory expectations
2. GMP Gap Assessment & Review
We evaluate existing systems, identify compliance gaps, and recommend corrective actions
3. Inspection Readiness
We conduct mock inspections, audit preparation, and documentation reviews to achieve inspection-ready status
4. GMP Training Programs
Our expert team deliver practical training to strengthen GMP knowledge, inspection preparedness, and quality culture
5. Quality System Harmonization
We aim to align Pharmaceutical Quality Systems (PQS) with PIC/S GMP requirements and international best practices
- Our Audit Framework
6. Regulatory Risk Assessment
Our inspector assist in identifying compliance risks, prioritizing remediation activities, and supporting CAPA implementation
7. Global Regulatory Support
Assist organizations in meeting PIC/S, WHO-GMP, FDA, and EMA expectations
8. Regulatory Communication Support
Our team assist to prepare responses, documentation, and communications for regulatory inspections.
9. Quality & Compliance Advisory
We provide expert guidance on quality management systems, documentation, and continuous GMP improvement.
10. Industry Collaboration & Best Practices
Share global regulatory insights and best practices to support sustainable compliance and operational excellence
- Why Choose Zenovel ?
- Expert Regulatory Guidance
- Our team excels in understanding GMP and PIC/S requirements, enabling confident navigation of complex regulatory expectations.
- End-to-End Compliance Support
Comprehensive support is offered throughout the certification process, including gap assessments, documentation review, training, mock inspections, CAPA implementation, and inspection readiness.
- Tailored Solutions
Our approach is tailored to align with your manufacturing processes, quality systems, and business objectives for effective compliance.
- Commitment to Quality and Success
We focus on building sustainable quality systems that not only support successful PIC/S certification but also drive long-term regulatory compliance and operational excellence
People Also Ask (FAQs)
No. PIC/S does not certify pharmaceutical companies. Regulatory authorities conduct GMP inspections based on PIC/S guidelines and may issue GMP compliance certificates according to their national regulations.
PIC/S compliance helps organizations:
- Improve product quality
- Strengthen regulatory compliance
- Enhance inspection readiness
- Build global market credibility
- Support international business expansion
PIC/S compliance is not mandatory in every country, but many regulatory authorities adopt PIC/S GMP standards. Compliance is often beneficial for companies seeking international market access.
The timeline depends on your current compliance status and facility size. Preparation may range from a few weeks to several months.
Simply contact our regulatory team for an initial consultation. We'll assess your current compliance status and develop a customized roadmap to achieve PIC/S GMP inspection readiness.
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