Quality Control/Quality Assurance
 Requirements for Good Manufacturing Practices (GMPs) are regulated by Part C, Division 2 of the Canadian Food and Drug Regulations. The GMPs note specific requirements for the procurement of materials, manufacturing, packaging/labelling, testing, storage, distribution and release of drug products.
Where DSA acts as the Canadian Quality Control Department for manufacturers, packagers/labellers, importers, distributors or wholesalers, we help you ensure that you meet your responsibilities with respect to the GMPs.
Whether we act as your contract Quality Control/Quality Assurance department or supplement your in-house departments, can assist you with the following compliance activities:
Contact us today to find out how we can help you understand Canadian GMPs and how they impact your company. For more information on services offered, click here to request a copy of our free brochure.
Documentation Review and Approval
We help ensure that your company holds all the information required under Canadian Good Manufacturing Practices (GMPs).
We review your master production documents and your batch documentation to ensure compliance with GMP. We offer valuable expertise for review and approval of batch deviations, reprocessing and rework. We ensure your documentation is comprehensive enough to meet Health Canada expectations.
We review your cleaning, process and equipment validation protocols to ensure compliance with Canadian GMPs and/or ICH guidelines. We then review your validation data and/or data summaries to ensure compliance with your protocol. Our Consultants can provide valuable assistance in ensuring your protocols are satisfactory in meeting Canadian requirements, before you undertake your studies. We can assist you in preparing data summaries and conclusions and if needed, approve your final reports.
We review your stability protocols to ensure your compliance with Canadian GMPs and/or ICH guidelines and/or marketing authorization. We then review your stability data to ensure compliance with your protocol. Our Consultants can provide valuable assistance with investigation of OOS (out-of-specification) and OOT (out-of-trend) results.
For clients who have in-house quality control or quality assurance departments, we can handle your excess workloads by helping you clear your backlogs for documentation review. We can handle your documentation review projects on a full-time, part-time, or on an as-needed basis to cover staff shortages due to vacation or other absences.
Contact us today to ensure you are meeting your documentation responsibilities under Canadian GMP. For more information on services offered, click here to request a copy of our free brochure.
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Product Releases
Where DSA acts as your Quality Control Department, we hold the responsibility for releasing drug & biologics products into the Canadian marketplace. We can handle your product releases on a full-time, part-time, or on an as-needed basis to cover staff shortages due to vacation or other absences.
We review lot specific production documents to ensure compliance with the master production document. Where required by GMPs, we arrange for confirmatory analytical testing. If all documents are satisfactory, we promptly release products for sale in Canada.
Wherever possible, we recommend reduced testing programs and use of “unique identifier” testing exemptions which allow our clients to save on costly lab testing costs and help us to expediently release products into the marketplace. Let us review your product line-up to determine if there are any testing efficiencies that are not being realized.
Contact us to find out more about how DSA can take over responsibility for your product releases, act as your Quality Department or supplement your existing team. For more information on services offered, click here to request a copy of our free brochure.
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Audits & Self-Inspection
One of our trained Consultants can develop, implement, manage and/or administer your self-inspection programme. DSA can carry out the full self-inspection programme (audit of the Quality Control function) to ensure compliance with the Good Manufacturing Practices (GMP) and requirements for Annual Product Review.
Additionally, we can handle related activities for audits of your contract fabricators, packagers/labellers, testing laboratories, importers, distributors, or wholesalers.
Prior to entering into a business relationship with a new party, use our services for an independent due diligence assessment. We will provide you with an impartial assessment on the firm’s GMP compliance. Our auditors are ASQ certified and are trained to carry out audits to assess compliance with GMP (Good Manufacturing Practices) and HACCP (Hazard Analysis Critical Control Points). We can lead audits on your behalf or offer additional expertise to supplement your in-house audit teams.
Contact us, to find out more about how DSA can manage your audits or self-inspection activities. For more information on services offered, click here to request a copy of our free brochure.
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Stability Programs
Stability Requirements can be found in Sections 27 and 28 of the Good Manufacturing Practices (GMPs).
For clients that need to establish shelf life, we help ensure your compliance with Section 27 of the GMPs and related ICH Guidances (International Conference on Harmonization). For clients that need to monitor changes to shelf life and on-going stability, we help ensure your compliance with Section 28 of the GMPs.
We can help you set up accelerated and room temperature studies. If needed, we can draft protocols for you to implement within your labs. Alternatively, we can implement and manage your stability programs for you. We can also provide valuable input on the design and format of your data templates to ensure that information required by Health Canada is recorded for review.
We review your stability protocols to ensure your compliance with Canadian GMPs and/or ICH guidelines and/or marketing authorization. We then review your stability data to ensure compliance with your protocol. Our Consultants can provide valuable assistance with investigation of OOS (out-of-specification) and OOT (out-of-trend) results. Where needed, our Regulatory Team can prepare filings to Health Canada to support changes to the approved shelf life or stability commitments.
DSA can also be of assistance in drafting protocols or monitoring programs for challenge studies such as freeze/thaw studies which will generate excursion data for transportation and shipping conditions.
Contact us to find out more information on how DSA can be of assistance in helping you develop or manage your stability programs. For more information on services offered, click here to request a copy of our free brochure.
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Complaints and Adverse Drug Reactions
Complaints
The Good Manufacturing Practices (GMP) require that you have established procedures in place for handling of complaints. If you sell drugs, and you currently don’t have established procedures for these activities, then DSA can develop programs for you, which meet these regulatory requirements.
If you don’t have resources on staff to assist you with investigations into quality complaints, then DSA can provide you with this expertise. We can review complaints, spearhead the investigation into the complaints, either directly or by dealing with your fabricators, and then ensure that the complaint can be closed out and resolved.
Adverse Drug Reactions
DSA can help you develop protocols which delineate your responsibilities for reporting, if and when, adverse drug reactions occur.
DSA can help you determine if your reactions meet the requirements for adverse drug reaction reporting and can prepare the filings on your behalf. We can also assist you with the investigation and advise you on whether or not your investigations are sufficient to meet regulatory expectation.
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Standard Operating Procedures
The GMP Interpretative Guidelines define a Standard Operating Procedure (SOP) as a written procedure giving instructions for performing operations not necessarily specific
to a given product or material but of a more general nature.
SOPs are used to describe all facets of drug manufacturing to drug distribution and post-marketing compliance.
For clients with existing SOPs, DSA can work with your team to review your SOPs against regulatory requirements and prepare a gap analysis to outline any shortcomings. For new clients, DSA will develop SOPs for your organization which will guide you in compliance with GMPs.
Some companies fall into a trap of writing SOPs which are too detailed for staff to follow. Other companies prepare SOPs which are too brief to offer any guidance to staff on how to comply with GMP. DSA specializes in preparing SOPs that are succinct, effective and easy to follow.
Contact us, for more details on how we can help prepare new SOPs or revamp your existing SOPs. For information on other services offered, click here, to receive our free brochure.
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Site Reference Files
Health Canada allows companies to prepare and submit Site Reference Files for review. The purpose of the Site Reference File is to provide an over view of the firm’s compliance with GMP. There are several section of the Site Reference file which will provide an overview of the premises of the establishment, the activities carried out, the personnel who run the organization and administer Good Manufacturing Practices (GMP), the equipment used, and the specifications in place to ensure adherence to quality.
Site Reference Files should facilitate Drug GMP Inspections by allowing the Inspector to familiarize themselves with the operation prior to inspection, allowing the actual inspections to take less time as the Inspector only needs to verify information.
DSA can prepare Site Reference Files for submission to Health Canada. We can also review your existing Site Reference Files and audit your organization to determine what updates need to be filed with Health Canada.
Contact us to find out more about DSA Consultants can be of assistance to you. To receive our free brochure, click here.
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Annual Product Reviews
Annual Product Reviews have long been a requirement for compliance with cGMPs (United States current Good Manufacturing Practices). Although Health Canada has always had a requirement for “self-inspection”, the 2007 GMPs now formalize specific requirements for “annual product quality reviews”.
DSA can assist you with preparing protocols for annual reviews or actually completing these reviews on your behalf. We also offer services to review or audit the reviews completed by your staff.
Contact us today to find out how DSA can assist your organization with the preparation of your annual reviews. For more information on services offered, click here to request a copy of our free brochure.
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Contact us, to find out more information on Complaints and Adverse Drug Reaction Reporting and how DSA can be of assistance to you. Or click here, to receive our free brochure.
DSA Consultants Can Help You Solve the Government Regulation Puzzle.
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Call DSA Consultants today to discuss your unique professional needs.
(905) 827 - 0057
1660 North Service Road East, Units #106 & 107
Oakville, ON, L6H 7G3
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