Quality & Compliance Services Inc.
Quality & Compliance Services Inc. provides the pharmaceutical, natural health product, and medical device industries and their suppliers with services in the fields of compliance and quality control. Our dedicated and knowledgeable specialists can provide expert assistance at every stage of a compliance program from initial gap analysis through to satisfaction of GMP/NHP requirements and/or ISO registration.
Quality & Compliance Services Inc. is based in Mississauga (Toronto), Ontario. Since its incorporation in 1994, Quality & Compliance Services Inc. has built a client list ranging from independent packagers and importers through to some of the world's largest pharmaceutical manufacturers. Our offerings include:
Large Compliance Project Consulting
Fixed price audits
Quality Control Officer (QCO) Services
ISO 9000 and ISO 13485/13488
ICH Q7A GMP for APIs
Large Compliance Project Consulting
Quality & Compliance Services Inc. can help your company deal successfully with many specialized tasks, from the design of a complete Quality System through to assistance with all facets of ISO registration. Services include:
Project management of large GMP-related studies.
Quality assurance projects.
GMP implementation for clinical trial products.
Call on us when you require expert guidance and proven effectiveness.
The GMP Gap Analysis
Quality & Compliance Services Inc. can pinpoint problems and their solutions, ensuring that your facility or operation meets GMP/ISO requirements. We will conduct a gap analysis on your Quality Systems. Then we will develop and deliver a prioritized compliance action plan based on this analysis, specifying how to prepare for your impending audit successfully.
We can perform full self-inspection activities as required by the Canadian GMP.
Third Party Supplier Audits
Quality & Compliance Services Inc. provides third party supplier/subcontractor audits of:
Raw material suppliers
All audit findings are presented in a detailed audit report, prepared in our own format or conformed to yours.
Quality Control Officer Services
GMP guidelines require that all fabricators, packagers/labellers, distributors and importers of drugs have in place a distinct, independent Quality Control department responsible for GMP activities, including product disposition (lot release). As your Quality Control Officer, Quality & Compliance Services Inc. will fully satisfy that requirement.
Quality & Compliance Services Inc. provides Quality Control Officer services to a wide range of clients. Our services include:
Handling communication and correspondence with Canada's Health Products and Food Branch Inspectorate (HPFBI; formerly known as TPP).
Hosting HPFBI inspections.
Holding all sensitive documents and information (if desired).
Performing the annual self-inspection.
Evaluating GMP compliance of suppliers and subcontractors.
Coordinating product testing.
Dispositioning product (releasing drug product for sale in the Canadian market).
Technical Writing Services
Meet GMP/ISO documentation requirements and deadlines in a cost-effective manner, with reduced disruption of day-to-day operations.
Quality & Compliance Services Inc. technical writing services ensure:
Finished Standard Operating Procedures (SOPs) and related documents are clear, accurate and easy to use.
All documents are written in company's preferred style/format.
Work is completed quickly; our studies show that your staff saves (on average) 80% of the time it would take for them to generate the technical document themselves.
Work is performed with minimal intrusion: most work is done off-site; office space, computers, support staff, are not required from client.
You avoid hiring new permanent or contract employees.
Your existing staff stays focused on regular business.
Impact on your bottom line is minimized.
Bring your company into compliance with GMP requirements, and profit from a better trained, more efficient and effective workforce. Quality & Compliance Services Inc. designs, develops, and delivers targeted GMP training to audiences ranging from line operator to management.
We will develop customized courses to meet your unique requirements, or deliver our overview course, 'Fundamentals of GMP,' which includes instruction on the following:
Understand the concepts of GMP regulations.
Understand the importance of GMP compliance.
Understand the Manufacturing Cycle.
Apply GMP regulations to the Manufacturing Cycle.
Develop a personal Action Plan to ensure compliance at your company.
Benefits of this course include the following:
Obtain a basic understanding of GMP regulations and how they apply to the Manufacturing Cycle.
Apply GMP regulations to ensure compliance levels are met.
Meet government training requirements.
Our courses feature interactive exercises, case studies, and hands-on tasks designed to involve and engage the participant. Courses can be customized to incorporate company-specific examples and documents. You can also choose to have us develop a curriculum based on a needs analysis of your organization.
Your staff will benefit from our facilitators' broad-based experience in quality control and quality assurance, GMP, ISO 9000, and technical documentation. Quality & Compliance Services Inc. can provide on-site delivery, working closely with you to reduce scheduling conflicts. We can also help you put in place a system for training effectiveness evaluation, as required by GMP guidelines.
NHP submissions - site licence (SLA), product licence (PLA).
Common Technical Documents (CTD) preparation.
Post-Marketed Drug Services:
Changes to marketed products
Establishment Licence applications and amendments.
New system implementation
Upgrade to ISO 9001:2000
Technical writing of policies, procedures, work instructions, and records.
ISO 13485/8 Overview (1 day)
ISO 13485/8 Essentials (2 days)
ISO 13485/8 Comprehensive (3 days).
ISO Support Services:
Ongoing quality system services (e.g., monthly maintenance)
Quality & Compliance Services Inc. works systematically, within pre-determined timelines, as we:
Perform the Validation Gap Analysis
Write or revise the Master Validation Plan
Develop and execute Protocols
Develop a detailed Implementation Plan with priorities, timelines, etc.
Clients come away with a clear plan to address validation needs.