The regulatory expectation is that equipment, control systems and processes used to fabricate, store, distribute and test health products need to be qualified and validated. We have experienced and knowledgeable consultants who can ensure that all qualifications and validations are properly conducted and documented.
Equipment and Systems Qualification
Equipment and systems used to fabricate, package, label, store, transport and test health products should be qualified and approved prior to first use. Our consultants are knowledgeable and experienced to qualify equipment used for all dosage types of health products. Examples of critical systems we can qualify are,
We specialize in the validation of processes used to fabricate, package, label health products of all dosage types for example, solid oral dose, liquids, creams and ointments. Examples of fabrication processes are granulation, tablet compression, coating and filling. Our consultants will provide their expertise in writing and executing protocols, reports and executive summaries.
In our validation work we also include the use of appropriate statistical tools to evaluate the process capability of the fabrication processes. Our ultimate goal is to deliver our experience and expertise to assure the quality of health products.
The assurance of the cleaning procedures of equipment used for fabrication, filling and packaging is a definite requirement. Our consultants can work closely with cross-functional departments, for example, Validation, Quality Assurance, R&D and Engineering. Our experienced consultants can do the following:
Ardent Consultants has the expertise to conduct temperature and humidity mapping of your material and product storage areas such as,
Our consultants will prepare, execute protocols, prepare the final reports, and ensure that your temperature controlled environments meet the regulatory requirements.
Shipping Route Qualifications
Shipping routes should be qualified by means of a protocol. Our team can help in developing a matrix of the shipping route of products requiring controlled temperature storage during transportation of health products to your customers or when shipped from your suppliers. We have the skills and knowledge to prepare a master plan, protocol and reports, taking into account the worst case scenarios.