Good Manufacturing Practice (GMP) Implementation
Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. Consumers expect the products they use are safe and effective. The primary regulatory standards for ensuring product quality are current Good Manufacturing Practices (cGMPs). Triskele’s team of GMP experts provides the guidance to implement and sustain quality management systems that assure proper design, monitoring, and control of manufacturing processes and facilities.
Good Laboratory Practice (GLP) Implementation/ISO 17025 Accreditation Readiness
Good Laboratory Practices (GLPs) are a set of principles that provides an operational framework for laboratories assure the quality and integrity of laboratory testing data in the support of safety of regulated products. ISO 17025 provides the requirements for testing and calibration laboratories to demonstrate that they operate a quality system, are technically competent, and are able to generate technically valid results. We work with you to establish proper laboratory controls and validation practices to operate a quality, compliant laboratory and to prepare your laboratory for ISO 17025 Accreditation.
Process Validation/Equipment Qualification Expertise
Validation is "Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes." Validation, along with proper equipment qualification, is a GMP requirement to prove control of critical processes and ensure operations serve their intended purpose. Our client’s success and credibility depend on their manufacturing facilities operating consistently and reliably. Our validation experts can help you achieve and maintain that reputation.
Standard Operating Procedure (SOP) Development
Standard Operating Procedures (SOPs) are written documents that define step-by-step instructions to complete a task. SOPs ensure controlled and consistent performance, facilitate employee communication, increase productivity, create a safe work environment, and support proper training and credentialing of employees. Creating a set of SOPs for your organization is essential to establishing an effective and compliant GMP program.
Audits are performed to ascertain the validity and reliability of information and to provide an assessment of an organization’s internal control. Companies that manufacture products for human and/or animal consumption must be able to prove reliability, accuracy, and consistency. From design qualification to performance qualification steps, the auditing process includes writing and review of validation policies, guidelines, and SOPs. Triskele Quality Solutions team members are Certified Quality Auditors (CQAs) through the American Society for Quality (ASQ). We have the knowledge, expertise, and experience to help you prepare for regulatory inspections and audits.
- Pre-approval Inspection Preparedness (PAI PREP)
- Third-party audits and assessments
- Gap analysis:
- Good Manufacturing Practice (GMP)
- Good Laboratory Practice (GLP)
- Good Clinical Practice (GCP)
- Quality System Review (QSR)
- International Standards Organization (ISO)
- Third-party certification
- Mock regulatory inspections
- Due diligence audits and assessments
Packaging and Labeling Expertise
The role of compliant product labeling in identifying and explaining what a product is and does is of the utmost importance. A text error in dosing instructions, expiration dates, ingredient lists, or illegible and/or missing information could amount to dire consequences for the end consumer, loss of revenue for the manufacturer, and could result in regulatory enforcement action. Additionally, consumers must be able to trust that the integrity of the package has not been compromised and that they are receiving safe products. Establishing proper packaging and labeling specifications and requirements is crucial to any manufacturing operation. Let our 15 years of packaging and labeling experience help you avoid these potentially costly mistakes.