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Validation

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PharmEng has an extensive background in completing Validation Projects; these include cleaning, facility and utility, equipment, process, and computer validations.

 

  • Process Validation +

    PharmEng professionals possess experience in validating pharmaceutical and biopharmaceutical manufacturing processes. Our team of experts will prepare necessary protocols incorporating all critical parameters of the process. Execution will incorporate data analysis and resolve any non-conformances. PharmEng will collect and evaluate data to ensure that a process is capable of consistently operating according to determined standards. Our professionals provide effective process validation which contributes significantly to assuring drug quality.

    Our project execution will include evaluating the process capability of the manufacturing and testing procedures using statistical techniques. By teaming up with the R&D, Operations, Quality Assurance, Regulatory Affairs personnel, PharmEng will ensure that all regulatory requirements and specifications are met.

    Our project management skills will ensure that all documentation, written and provided, will meet the standards of international regulators and the Quality Assurance team. Our team's results and deliverables are well accepted by FDA and Health Canada regulatory bodies. PharmEng will provide your company with results that exceed your expectations.

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  • Cleaning Validation +

    PharmEng possesses a group of highly experienced professionals for cleaning validation procedures that are recognized and exceeds the expectations of FDA and Health Canada regulatory bodies. Our consultants will utilize their skills and knowledge to ensure all parameters including worst case scenarios are tested for and validated. We understand the importance of complying with regulatory guidelines for the cleaning of all critical equipment.

    We can develop and execute cleaning protocols by challenging the current cleaning procedures in extreme case conditions to ensure the protocol will be effective during any given manufacturing situation. In addition, we will determine the most effective analytical methods and rationalize the appropriate limits for the acceptance criteria.

    PharmEng has a proven track record of excellence by developing Cleaning Validation master plans, cleaning validation protocols, and swab recovery studies. We strive to personalize our services to cater to your company standards by working closely with your validation, engineering, quality assurance and regulatory affairs department.

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  • Computer Validation +

    Computer systems have become an integral part of the manufacturing process for regulated products. Regulatory agencies have taken the approach that the verification of computerized processes requires additional testing, and they have developed specific criteria for validating computer systems.

    At PharmEng, we feel that the validation of computer systems not only ensures compliance to these regulatory standards, but also enhances the integrity of your automated processes and your electronic data. Whether you are implementing a complex LIMS application or would like to validate an Excel spreadsheet, PharmEng has the expertise to ensure compliance of your computerized systems.

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