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Quality Assurance & Quality Control

Our Services Include:

Quality Assurance and Quality Control are two aspects of quality management. While some Quality Assurance and Quality Control activities are interrelated, the two are defined differently. Typically, Quality Assurance activities and responsibilities cover virtually all of the quality system in one fashion or another, while Quality Control is a subset of the Quality Assurance activities. Also, elements in the quality system might not be specifically covered by QA/QC activities and responsibilities but may involve QA and QC.

Quality Assurance

Quality Assurance can be defined as part of quality management focused on providing confidence that quality requirements will be fulfilled. The confidence provided by Quality Assurance is twofold—internally to management and externally to customers, government agencies, regulators, certifiers, and third parties. An alternate definition is all the planned and systematic activities implemented within the quality system that can be demonstrated to provide confidence that a product or service will fulfill requirements for quality.

Quality Control

Quality Control can be defined as part of quality management focused on fulfilling quality requirements. While quality assurance relates to how a process is performed or how a product is made, quality control is more the inspection aspect of quality management. An alternate definition is the operational techniques and activities used to fulfill requirements for quality.

With Quality Assurance and Quality Control in mind, RLS Pharma Services offers the following services:

Documentation Review and Approval
Verifying and approving production documents
Performing product release
Managing stability studies
Writing and implementation of Standard Operating Procedures (SOP’s)
Day to day quality assurance
Master document writing and review
Self-inspection (internal audit)
External audits of your various suppliers (Canadian or foreign)
Compliance gap analysis
Regulatory compliance assistance
Temperature Mapping & Qualification
Preparation and renewals of Drug or Medical Device Establishment License / NHP Site License
Training: Good Manufacturing Practices (GMP), Standard Operating Procedures (SOP’s), Regulations, specific needs, etc.
Liaison with Health Canada and International Regulatory Authorities for Inspections, audits and submissions
Pre-inspection preparation and planning
Manage and assistance during Health Canada inspections or clients auditing
Prepare post-inspection corrective action responses
Regulatory due diligence
Design and implementation of corrective measures
Annual Product Quality Reviews (APQR)
Adverse Reaction Reporting
Pharmacovigilance Activities
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