PSCI Certification: Pharmaceutical Supply Chain Initiative

PSCI audits play a pivotal role in enabling transparency and efficiency in the supply chain. Unlike one-time compliance inspections, PSCI audits offer a sustainable platform for:

– Reducing Audit Duplication: Shared audit model helps avoid multiple audits by different customers.

– Enhancing Supplier Visibility: Suppliers who share their audit reports gain recognition and credibility with PSCI member companies.

– Identifying Risks and Gaps: Enables early identification and resolution of operational, social, environmental, or ethical issues.

– Driving Corrective and Preventive Action: Focused CAP development supports continuous improvement and regulatory alignment.

– Encouraging Transparency and Trust: Open information exchange builds a reliable supplier base across geographies.

– Reducing Audit Fatigue: Helps allocate internal resources more efficiently across various compliance obligations.

1. Member-Initiated Audits

These are audits initiated and often sponsored by PSCI member companies. The member will select suppliers for assessment and engage approved third-party audit firms or qualified internal auditors. The audit results are usually shared with the initiating member but may be extended to other members with supplier consent.

2. Supplier Self-Initiated Audits (SSIA)

Suppliers can proactively nominate themselves for a PSCI audit using an approved audit firm. This self-paid route allows greater flexibility in scheduling and scope and ensures proactive identification of risks and improvements.

Key Advantages of SSIA:

– Flexibility over timing, scope, and auditor selection.

– Faster audit readiness and reduced waiting time.

– Opportunity to address findings before customer requests.

Increased visibility and credibility among PSCI members.

3. Audit Modalities Supported

– Onsite Audits: Physical presence at the facility for full-scope assessment.

– Partly Remote Audits: Combination of onsite and remote audit practices using digital tools.

– Fully Remote Audits: Entirely digital audits conducted through video conferencing, live tours, and document sharing platforms.

Each format includes the same PSCI principles and assessment rigor, ensuring no compromise in audit depth.

Organizations involved in manufacturing medical products or supplying materials to pharmaceutical and medical device industries—including raw material suppliers, contract manufacturers, logistic providers, and service vendors—are eligible for PSCI certification

Suppliers are categorized based on operational complexity:

• “A” Suppliers: Service providers with lower HSE risk, such as logistics or IT support firms.
• “B” Suppliers: Component and material suppliers, including packaging and intermediate providers.
• “C” Suppliers: Core suppliers and contract manufacturers, especially involved in API or chemical manufacturing.

Each category determines the applicable PSCI SAQ and Audit Template (Full or Abbreviated).

1. Preparation & Planning
   –Review of PSCI scope and audit type
   -Completion of SAQ and pre-audit checklist
   – Review of site-specific risks and applicable regulations
2. Audit Execution
   – Opening meeting
   – Site walkthrough and observation
   – Worker and management interviews
   – Review of HSE, labor, ethics, and environment documentation
   – Closing and pre-closing meetings
3. Reporting & CAP Development
   – Audit report generation by auditors
   – Drafting and submission of the CAP with timelines
   – Tracking progress and submission of evidence
4. Audit Sharing & Follow-Up
   –Upload to PSCI platform
   – Sharing permissions management
   – Support for re-audit or corrective action verification (if needed)

– A stakeholder could be defined as a group of individuals without whose provision the organization would cease to exist. There are multiple stakeholders in a pharmaceutical supply chain which includes raw material suppliers, manufacturers, distributors, regulatory authorities, pharmacies, hospitals, and patients.

– In the areas of ethics, labour, health and safety, environmental protection, and management systems, the PSCI audit program is meant to evaluate a supplier’s performance against the PSCI principles, as well as international standards and agreements and local regulatory requirements.

– There are three main objectives are to:

1. 1. Drive leadership practices at member companies
   2. Enable suppliers to continuously improve
   3. Improve engagement across the industry and with key stakeholders

– Auditing makes it easier to decide whether or not a provider is acceptable. Companies can actively qualify as suppliers and set themselves apart from the competition by doing so. Risks associated with how on-site activities are carried out can be identified and prioritized. Supplier companies are also trained on regulatory needs and expectations. As a result of the audit, customers and business partners have more faith in you.

Our PSCI audit support is ideal for:

– API and Intermediate Manufacturers

– Pharmaceutical and Biopharma Production Units

– Packaging and Formulation Suppliers

– Laboratories and R&D Centers

– Warehousing and Logistics Providers

– Engineering, HR, and Facility Management Vendors

Any supplier in the healthcare and pharma value chain can benefit from aligning with PSCI’s framework.

1. Pre-Audit Preparation

We provide full assistance in preparing for PSCI audits:

• Completion and validation of the Self-Assessment Questionnaire (SAQ)
• Review and organization of documents from the Pre-Audit Document Request List
• Conduct of internal readiness assessments and gap analysis
• Worker and management awareness sessions
• Coaching for document control and interview preparedness
• Ensuring familiarity with PSCI codes, maturity models, and risk areas

2. Audit Facilitation

On the day(s) of the audit, we provide:

• Coordination with auditors and internal teams
• Real-time support during document reviews, facility tours, and interviews
• Management of logistics and audit agenda execution
• Facilitation of smooth communication with auditors
• Ensuring safe audit conduct protocols and confidentiality

3. Post-Audit Corrective Action Planning (CAP)

We help interpret audit findings and develop a detailed, time-bound Corrective Action Plan (CAP):

• Root cause analysis of non-conformities
• Action item formulation and responsibility assignment
• Documentation of implementation evidence
• Progress monitoring and auditor liaison for follow-ups
• Support for follow-up audits, reviews, and evidence upload

4. Audit Report Sharing Support

After the audit, suppliers have the option to share the audit report via the PSCI platform. We help with:

• Understanding the Data Sharing Agreement (DSA)
• Uploading documents to the PSCI platform
• Managing visibility to specific PSCI members or the entire network
• Ensuring compliance with confidentiality and data protection norms

– Expertise: Experienced in supporting PSCI audits across various supplier categories and regions.

– Compliance Knowledge: In-depth knowledge of Indian and global regulatory standards.

– Strong Documentation Support: Extensive templates, trackers, and technical guidance.

– End-to-End Solutions: Covering audit readiness, execution, and CAP follow-ups.

– Proven Track Record: Successfully supported multiple clients through high-impact audits.

– Scalable Approach: Suitable for MSMEs, large manufacturers, and service providers alike.

– Trusted Industry Partner: Recognized for ethical standards and practical, business-aligned advisory.