GMP Audits: Ensuring Manufacturing Excellence
RxCloud offers comprehensive GMP audits to ensure your manufacturing processes, equipment, and facilities meet industry standards. Our use of pre-written questionnaires and a deviation database ensures thorough, efficient audits across all key areas.
What Our GMP Audit Covers:
- Quality Management Systems (QMS): Ensure compliance with industry-specific quality standards.
- Facility and Equipment Audits: Ensure your production environment meets regulatory and safety requirements.
- Personnel Qualification: Evaluate staff training and qualifications to ensure proper execution of SOPs.
- Raw Materials and Components: Audits to confirm the integrity and quality of inputs used in manufacturing.
- Production Processes: Comprehensive review of production flows and control systems.
- Packaging and Labelling: Verification of labeling accuracy and compliance with packaging regulations.
- Laboratory Controls: Evaluate the accuracy and reliability of your lab testing procedures.
- Documentation and Record Keeping: Ensure full compliance with documentation requirements to avoid regulatory issues.
- Complaint Handling and Product Recalls: Examine your processes for managing customer complaints and recalling faulty products.
- Validation and Qualification: Review of process validation to ensure consistent product quality.
- Regulatory Compliance: Ensuring adherence to local and global regulatory standards.
What is Good Manufacturing Practice (GMP)?
Good Manufacturing Practice (GMP) refers to the systems and processes that make sure products are consistently produced and controlled according to established standards. It’s a set of guidelines that ensures the safety, quality, and efficacy of pharmaceutical and life science products, covering all aspects of production. From raw materials, equipment, and premises to the training of staff. Good Manufacturing Practice (GMP) regulations focus on minimizing risks in production that cannot be fully eliminated by testing the final product.
What is cGMP?
Current Good Manufacturing Practice (cGMP) builds upon GMP by emphasizing the “current” best practices and technologies that should be followed in the industry. It reflects the expectation that manufacturers stay up-to-date with the latest advancements in technology, quality control systems, and scientific standards.
So how do we approach GMP regulations for your business?
At RxCloud, our approach to Good Manufacturing Practice (GMP) regulations is designed to make sure your suppliers meet the highest standards of quality, safety, and compliance. We tailor our services to fit your specific needs, from the initial assessment to ongoing monitoring.
Our GMP Audit Approach
- Initial Assessment & Gap Analysis: We start with a thorough pre-assessment of entire supplier processes and systems to identify gaps and areas for improvement, ensuring alignment with GMP guidelines.
- Customized Compliance Strategy: Based on the pre-assessment, we draft a tailored audit strategy that aligns with global standards and regulations.
- Process Validation & Qualification: We ensure your production processes consistently meet standards by validating equipment, raw materials, and methods to maintain GMP compliance.
- Documentation & Record Keeping: We ensure your suppliers are following proper documentation practices, ensuring all records are accurate, up-to-date, and traceable.
- Facility & Equipment Audits: Our experts review all facilities and equipment for cleanliness, maintenance, and layout to prevent contamination and ensure quality.
- Ongoing Monitoring & Support We provide post-audit support to help your business stay compliant with evolving GMP regulations.
Elevate Supplier Standards with RxCloud’s GMP Services
By partnering with RxCloud for our Good Manufacturing Practice (GMP) services, you can be rest assured that your suppliers will operate at the highest level of quality and safety. Our goal is to help you minimize risks, enhance product quality, and maintain compliance with all relevant regulations.
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Frequently Asked Questions (FAQs) – GMP Audits
It is like having a full ‘health check’ of your whole manufacturing process. A GMP audit is a systematic review identifying whether your operations consistently meet strict quality standards and regulatory requirements. It will verify anything from your equipment and facilities to training records and all of the necessary documentation.
The GMP compliance audit is not just there to check a box around regulatory compliance; it is your strongest weapon against product failures and recalls. GMP audits allow you to:
Find risks earlier, both saving time and money.
Build confidence in you with regulators, partners, and consumers.
Show that you are dedicated to product safety and product quality.
No two facilities are alike, but a strong GMP audit checklist will address some universal pillars of quality:
- People – Proper hygiene and training.
- Process – Reliable and consistently followed production steps.
- Place – A clean, suitable, well-kept facility.
- Paperwork – Accurate and complete documentation.
- Products – Controlled flow of materials from the supplier to the finished product.
It is a formal evaluation that leads to official recognition. A GMP Certification audit is performed by an accredited third party for evaluation of your quality management system to ensure it meets all of the requirements of a specific GMP standard. Having this certification is an assertive legitimization of quality in the global marketplace.
Your internal audits are practice, and driving continuous improvement is the objective. A formal GMP compliance audit is the “championship game.” It is designed to be rigorous, comprehensive, and objective, specifically to assess your readiness for scrutiny by the regulatory authority or certification.
Yes, and this is where expertise matters. Pharmaceutical GMP audits are much more stringent due to the product’s criticality. Pharmaceutical GMP audits involve a level of understanding with the regulatory bodies, for example FDA and EMA, and a level of scrutiny regarding sterility, data integrity, and purity of product.
For the majority of companies (especially in pharmaceuticals), it is good practice to schedule an audit annually. Regular GMP compliance audits keep your quality system engaged and will give you assurance that you are prepared for an unannounced regulatory inspection at any time, even for the most demanding situations.
Having a fresh, external perspective is invaluable. Our professional GMP audit services will provide:
- An objective perspective that is free of the bandwidth issues of having an internal perspective.
- Deep understanding of evolving regulations.
- Actionable recommendations to address the identified issues and to enhance your organization’s overall quality culture.
We don’t just audit. We partner with you! Our GMP compliance audit services are designed to be cooperative. We will help guide you in an engaging pre-audit process, and carry out a fair and vigorous audit, and then provide you with a summarized, useful roadmap that will help you arrive at, and maintain full compliance.
Great. The first step is easy. Simply speak with us. We will get you on a path to a successful audit — whether you seek advice for an internal GMP audit, or whether you are seeking a full GMP certification audit.