In pharmaceutical industry materials are supplied from different suppliers. Supplier audits are a critical part to ensure the quality and safety of raw material, components, packaging materials and other outsourced services. Regulatory agencies like USFDA, EMA, MHRA, and WHO expect manufacturers to maintain a perfect supplier qualification program that includes internal audits, periodic reaudits and continuous performance monitoring.
Auditing a material supplier is not just taking a check box but it provides an opportunity to evaluate a supplier’s system, process and culture aligned with good manufacturing practices. In this post, we will explore the importance of supplier audits, what auditors look for during an audit, how suppliers can prepare for these audits and tips for maintaining a strong supplier relationship.
Pharmaceutical companies procure materials through supply chain. This includes active pharmaceutical ingredients, packing materials, contact manufacturing companies and other service providers. Any link from this supply chain can impact the product quality.
A strong supplier program can help to:
1. Pre-Audit Preparation: Auditors review company history, risk classification and send an agenda of audit to the facility to be audited.
2. Opening Meeting: In opening meeting introduction, scope, confidentiality agreements and audit plan are discussed.
3. Facility Tour: Actual audit is started with observation of manufacturing, storage, and laboratories.
4. Document Review: Checking SOPs, records, training, CAPA, and data integrity is conducted to ensure the product quality and consistency.
5. Interviews: Questions are asked to staff about processes and procedures to ensure the competency and training effectiveness.
6. Closing Meeting: After completion of audit observations, findings, and next steps are detailed by auditors.
The auditors may categorize findings as critical, major and minor, and it is important to respond to the CAPA timely and effectively.
A collaborative approach between staff and auditors builds trust and can even lead to fewer auditors’ visits overtime.
Supplier audits are essential in pharmaceutical companies to maintain product quality. It helps to safeguard product quality, patient safety and regulatory compliance. Auditors not only look paperwork but they also assess the culture, systems and procedures. In today’s world where quality is in focus, pharmaceutical companies must audit-ready and it is not optional but it is a business requirement.
Auditing a material supplier is not just taking a check box but it provides an opportunity to evaluate a supplier’s system, process and culture aligned with good manufacturing practices. In this post, we will explore the importance of supplier audits, what auditors look for during an audit, how suppliers can prepare for these audits and tips for maintaining a strong supplier relationship.
Why Supplier Audits Matter in Pharmaceuticals
Pharmaceutical companies procure materials through supply chain. This includes active pharmaceutical ingredients, packing materials, contact manufacturing companies and other service providers. Any link from this supply chain can impact the product quality. A strong supplier program can help to:
- Verify compliance with GMP, ISO standards and regulatory expectations.
- Ensure consistent quality of raw materials intermediates and packing materials
- Identify risks like data integrity issues, inadequate controls or sub stranded facilities.
- Protect companies from regulatory findings and product recalls.
- Implement continuous improvement process in supply chain.
What Auditors Look for in a Supplier Audit
Supplier audits are conducted on the basis of risks involved in different processes. The scope of audit depends on supplier’s role, criticality of material and past performance. Following are some areas on which auditors mainly focus during inspection.1. Quality Management System (QMS)
Quality management system is the fundamental requirement of any pharmaceutical manufacturing facility. Auditors will review quality policy and objectives, organizational structure and responsibilities, document control and record management systems, change control procedures, deviations and their corrective and preventive actions. A strong quality management system in any facility shows that quality is built into every aspect of the operations.2. Compliance with GMP and Regulatory Standards
Auditors verify that company is following relevant standards or not. Companies need to follow ICH Q7 for APIs, EU GMP for excipients and manufacturing, ISO 9001 for packaging suppliers and other country specific guidelines FDA 21 CFR part 210/211 etc. Supplier audits also include checking of training records, procedures and other physical controls.3. Facility and Equipment
Auditors generally visit the manufacturing and storage area to check cleanliness, maintenance and flow of materials. They also check segregation of materials to prevent cross contamination, qualification and calibration of equipment, HVAC and environmental monitoring systems, pest control systems etc. A well maintained facility indicates consistent product quality manufactured within it.4. Raw Material Control and Traceability
Row material control and traceability include approved supply list and qualification process, incoming material testing and release procedures, storage conditions and labeling, batch traceability and reconciliation of material. Auditors want to ensure that material used to manufacture pharmaceutical products is authentic, properly tested and traceable.5. Production and Process Controls
Supplied must have a validated and clearly defined process. Auditors will examine batch manufacturing records and batch packaging records, in process control and critical parameters, process validation documentation and procedures for handling deviations and nonconformities. These parameters show the consistency of product quality and compliance with specifications.6. Laboratory Controls and Analytical Data
If any supplier conducts testing of materials (like microbiological, chemical or physical testing of product), auditors will review method validation and verification, equipment calibration and maintenance, data integrity and handling of out of specification results. Data integrity is the main focus area for auditors these days.7. Personnel Training and Competence
Personnel training is also one of the interesting areas for the auditors. They check for training metrics and records, job descriptions and qualifications, ongoing GMP training and its frequency, personal hygiene and gowning practices for sterile manufacturing. Competent and qualified staff reduce the risk of contamination and errors.8. Deviations, CAPA, and Change Control
Auditors expect a perfect system for managing deviations and incidents. They also check investigations with documented root cause analysis, corrective and preventive actions with timelines and effective implementation, change control for processes, equipment and suppliers. Weakness in any of these systems shows problems in facilities during audits.How Suppliers Can Prepare for an Audit
As we discussed above, preparation is the key to a successful supplier audit. By following these steps supplier can be audit ready at all times.1. Maintain a Robust Quality Management System
Keep all the procedures up to date, approved and easy to accessible. Always conduct internal audits to identify the gaps before an external audit.2. Train Staff Regularly
Training in pharmaceutical industry has an important role. Staff must understand GMP principles, their responsibilities and how to respond to auditor’s questions during inspection. conduct mock audits and role-playing exercise to build confidence in staff members.3. Keep Facilities and Equipment Ready
Regular preventive maintenance, calibration and housekeeping are mandatory. Ensure right flows of personnel and material to minimize cross-contamination in manufacturing area.4. Organize Documentation in Advance
Organize documents and have a document readiness checklist for audits that includes quality manual, organizational chart, list of SOPs, recent batch records, calibration logs and training records etc. A well-organized documentation creates positive impression on auditors and saves time during supplier audits.5. Conduct a Mock Audit
Mock audits are simulations of actual audit by internal quality staff or third-party quality experts. Mock audit helps to identify weaknesses and prepare staff for real audit questions asked by auditors.6. Understand Your Own Data
Understand your key quantity matrix, market complaints and CAPA system. Be ready to discuss how you monitor and improve performance of your processes and systems.What to Expect During a Supplier Audit
A supplier audit follows a sequence of steps as below.1. Pre-Audit Preparation: Auditors review company history, risk classification and send an agenda of audit to the facility to be audited.
2. Opening Meeting: In opening meeting introduction, scope, confidentiality agreements and audit plan are discussed.
3. Facility Tour: Actual audit is started with observation of manufacturing, storage, and laboratories.
4. Document Review: Checking SOPs, records, training, CAPA, and data integrity is conducted to ensure the product quality and consistency.
5. Interviews: Questions are asked to staff about processes and procedures to ensure the competency and training effectiveness.
6. Closing Meeting: After completion of audit observations, findings, and next steps are detailed by auditors.
The auditors may categorize findings as critical, major and minor, and it is important to respond to the CAPA timely and effectively.
Common Findings in Supplier Audits
Following are some common findings observed during supplier audits.- Incomplete or outdated standard operating procedures
- Poorly controlled electronic data with no audit trails
- Unqualified equipment or HVAC system
- Inadequate personnel training
- Weak investigation of deviations and OOS results
- Lack of trending for complaints and environmental monitoring
Building a Collaborative Relationship with Auditors
An audit is not a checking of your system but it helps to improve the quality of product and regulatory compliance in the facility. Treat auditors as your partner in quality improvement. Always be transparent and don’t hide issues by providing data promptly and correctly. Listen to auditors carefully without defensiveness and implement CAPAs quickly and effectively.A collaborative approach between staff and auditors builds trust and can even lead to fewer auditors’ visits overtime.
Supplier audits are essential in pharmaceutical companies to maintain product quality. It helps to safeguard product quality, patient safety and regulatory compliance. Auditors not only look paperwork but they also assess the culture, systems and procedures. In today’s world where quality is in focus, pharmaceutical companies must audit-ready and it is not optional but it is a business requirement.
Frequently Asked Questions (FAQs) on Supplier Audits
Q1. How often are supplier audits conducted?
Answer: Critical suppliers for API and excipients are audited every one to two years while non critical suppliers may be audited every 3-4 years or after major process changes.Q2. What happens if a supplier fails an audit?
Answer: If any major nonconformance is found, the supplier must submit corrective and preventive action plan within a defined timeline and that should undergo a follow up to check the effectiveness of CAPA implementation.Q3. What is the role of a Quality Agreement in supplier audits?
Answer: A quality agreement defines the responsibility of both pharmaceutical company and supplier regarding GMP, documentation, change control and reporting deviations. It acts as a foundation for compliance and quality of the product.Q4. Are remote supplier audits acceptable?
Answer: Yes, remote supplier audits are accepted in some cases especially in post pandemic era. Remote supplier audits include digital documentation sharing and video workloads while critical suppliers like API manufacturers still require on site audits.Q5. How should companies trend and track supplier performance after audits?
Answer: You should maintain a supplier performance monitoring system that should track number and severity of findings, CAPA effectiveness, quality performance metrics and response time to deviations and change controls.
Get documents for Audit preparation in MS-Word FormatView List
No comments:
Post a Comment
Please don't spam. Comments having links would not be published.