VALIDATION CONSULTING SERVICES – Canada
What Is Validation?
Some Of The Topics Addressed In Our Validation Services
Some Of Our Areas Of Validation Expertise
Why Use Our Outside Validation Services?
What Is Validation?
This is “the documented act of demonstrating that any of your critical procedures, processes, equipment, materials, activities, or systems will consistently lead to expected results.” The most common are Process Validation (such as for cleaning) and Equipment Validation (such as for homogeneity of mixing)
Please note that GMP for NHPs and GPP for cannabis only requires “verification“, whereas GMP for drugs manufacturing / fabrication requires actual “validation“. So we focus on specific Quality Assurance (QA) programs such as GMP/cGMP for drugs, GLP for various chemicals, GCP for clinical trials, ISO 13485 / ISO 13488 (QMS) for medical devices, ISO 17025 for testing & calibration labs, and HACCP / ISO 22000.
Our validation consulting services can then be further broken down into the following categories:
- Concurrent Validations:
where current batches are used to monitor processing parameters;
- Retrospective Validations:
for products already being marketed, and based on extensive data accumulated over several lots and over time;
- Prospective Validations:
conducted prior to the distribution of either a new product or a product made under a modified process, where the modifications are significant;
- Installation Qualification:
to demonstrate that production equipment and ancillary systems are appropriately selected and correctly installed;
- Operational Qualification:
to demonstrate that production equipment and ancillary systems operate consistently in accordance with established specifications; and
- Process Qualification:
developing sampling and testing procedures for various stages of the manufacturing process to ensure that product specifications are met.
Some of the Topics Addressed in Our Validation Consulting Services
Our Validation Master Plan (VMP), states how the validation will be conducted, including:
- Purpose & Scope;
- Regulatory requirements;
- Roles & Responsibilities;
- List of key guidance documents (Health Canada, FDA, ICH, EU);
- List of required Protocols, SOPs and their associated quality records (forms, checklists), including:
- FAT (factory acceptance test) protocols vs. SAT (site acceptance test) protocols
- who will conduct the various tasks, and associated scheduling;
- defining the testing parameters & priorities (based on Risk Management, and other factors)
- identifying all input materials & equipment, as well as all other internal & external required resources;
- sampling plan & sample sizes;
- testing methods & specifications;
- calibration & maintenance;
- product characteristics;
- equipment to be used;
- number of batches to be used;
- defining acceptance criteria;
- determining the types of statistical methods to be employed & statistical analysis (accuracy, precision, std. deviation, CI, Paredo analyses, t-test, etc)
- determining when re-validation would be required; and
- specify who will sign / approve / disapprove the conclusions derived from the study.
Absence of the Validation Master Plan and supporting documentation will result in a non-compliance rating.
As one of Canada’s premier validation consulting companies, some of our expertise is in:
- Analytical methods such as: chromatography, spectroscopy, spectrophotometry, colourimetry, and most other modern laboratory techniques;
- Laboratory instrumentation such as: HPLC, GC, AA, ICP, MS, etc;
- Pharmaceutical production equipment such as: mixers, blenders, encapsulating / tableting machines, container fillers, cappers, shrink-wrappers / heat tunnels, labeling machines, weigh scales / load cells, etc;
- Process validation such as: % yields, contamination, homogeneity;
- Cleaning validation such as: microbial, product residues, cleaning agent residues, etc.;
- Utilities such as: HEPA systems (for air quality) and Purified Water systems (i.e.: RO units, conductivity / resistivity monitors, UV sterilization, and microbiology); and
- Software & hardware (electronic records & signatures for generation of batch orders, product counters, etc.) to 21 CFR Part 11 requirements.
Why Use Our Outside Validation Consulting Services?
- Allows full-time staff to concentrate on revenue-generating activities;
- No need to hire additional staff, then lay them off after the validation projects have been completed;
- Allows you to bring in our areas of expertise that your company may not have. This will speed up the validation project; and
- Aids in scheduling.
Our Summary Report of the Validation Studies can then be made available as an easy reference for your clients to review and approve.
Why use a consultant for your equipment or process validations?
Weighing the numerous pros & cons of bringing in a consultant vs. tackling it all in-house? Please see our web page “Why Use a Consultant” as part of that critical thinking process. Based in British Columbia, but covering all of Western Canada.