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Regulatory Compliance
Knowing the latest regulatory issues and rules/regulations is important for meeting compliance. GMP trends and FDA proposed concerns are constantly evolving and typically becoming more stringent. Keeping up on regulatory issues is a major focus of AKA. During facility planning, AKA can assist in design review, preconstruction FDA review, master planning, and on-going review for compliance during construction.
Qualification/Validation
Often a company has the manpower to execute the protocols but not the time to write them. AKA can assist your firm by writing validation protocols for installation qualification, operational qualification and performance or process qualification. The protocols will address current industrial standards and comply with the FDA's cGMP guidelines. Having a master validation plan describing a firm's project and validation goals is very useful in the early stages of a project. Master validation plans describing the technical aspects, equipment and processes acceptance criteria, and other project related issues can be compiled by AKA for your firm.
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AKA can help you and your company in the following areas by performing or offering assistance in:
GMP Audits
Master Planning
Project Review and Management
Design Review
Validation Issues and Concerns
Quality Assurance/cGMP Compliance
Regulatory Compliance Issues
Protocol Writing
Document Control
Standard Operating Procedure Writing
Preventive Maintenance Programs
Calibration Programs
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Aseptic Processing and Sterilization
Environmental Control
Isolation Technology
Sterilization Technology
Biologicals
Biotechnology
Bulk Pharmaceuticals
Pharmaceuticals
Solid Dosage Forms
Filling/Labeling/Packaging
Chemical Product Manufacturing
Quality Assurance/Quality Control
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