Design and implementation of Quality Management Systems
QiQ will facilitate your organization through and analysis of you existing status and assist you with the design and implementation of a QMS that is appropriate for your organization. The QMS will encompass the Six Systems Model; The Quality Systems, Materials Management and Controls, Facilities and Engineering, Production and Process Control, Packaging and Labeling and Laboratory Controls
Assistance with preparation and review of CMC regulatory submissions
Over 20 years of experience in the industry enables QiQ to offer assistance in your preparation of the Chemistry, Manufacturing and Controls section of your submissions, Annual Reports, Information Amendment and Site License Applications.
QiQ offers on-site training of your staff in Good Manufacturing Practices (GMP). In addition specific customized training programs on Documentation and Document Management, Validation, Equipment Cleaning and Sanitization etc. may be developed to meet your application and needs.
Validation program and implementation
The design and implementation of effective validation must an integrated program that encompasses the knowledge acquired from the Quality by Design program. The primary elements include but are not limited to the sourcing of raw materials & components, equipment and facility & utility systems, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), Process Performance Qualification (PPQ), Change Management, Monitoring, Data Review & Analysis, CAPA System, and Analytical Testing. QiQ can also assist with review and or preparation of validation protocols.
Conducting periodic audits is a key tool in your Quality Tool Kit. Many organization opt to outsource this activity to a third party. QiQ has performed many such audits on behalf of its clients. Among these audits are: Supplier (or Vendor) Certification Audits, Due Diligence Audits of Contract Manufacturers, Labs or Strategic Partners and GMP Audits.
Quality Assurance in the manufacture of products in the Health Care and related industries involves specific knowledge and experience relating to the technology, regulatory guidances, specified limits, applicable standards etc. QiQ can guide your personnel through the policies, procedures and applicable standards as well as train your in-house quality practitioners in the philosophy and practical application of GMP in the implementation of your Quality Assurance program. This include: Batch Review, Product Release, Annual Product Quality Review, Document Management, Deviation Management, Change Management, Product Complaint Management, Quality and Out-of-Specification Investigations etc.