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Process Validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting it's predetermined specifications and quality characteristics.". FDA Guideline on General Principles of Process Validation. Technical Services for Manufacturers of Pharmaceuticals and B iologics. GMP Contracting, Inc. To support Good Manufacturing Practices by always focusing on the guidelines, ensuring the ultimate goal - patient safety.

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Process Validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting it's predetermined specifications and quality characteristics.. FDA Guideline on General Principles of Process Validation. Technical Services for Manufacturers of Pharmaceuticals and B iologics. GMP Contracting, Inc. To support Good Manufacturing Practices by always focusing on the guidelines, ensuring the ultimate goal - patient safety.

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1 our objective

2 commissioning/validation

3 compliance improvement

4 technical training

5 compounding pharmacies

6 recent projects

7 customers

8 bestech

9 our mission

10 validation

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Process Validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting it's predetermined specifications and quality characteristics.". FDA Guideline on General Principles of Process Validation. Technical Services for Manufacturers of Pharmaceuticals and B iologics. GMP Contracting, Inc. To support Good Manufacturing Practices by always focusing on the guidelines, ensuring the ultimate goal - patient safety.

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Customers

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Chembio Diagnostics, Inc. New York Blood Center. Ohm Laboratories, Inc. Matt Bestercy (631) 838-9083 mbestercy@bestgmp.net. GMP Contracting, Inc. Technical Services for Manufacturers of Pharmaceuticals and B iologics.

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Commissioning/Validation

http://www.bestgmp.net/commissioning-validation.html

Technical Services for Manufacturers of Pharmaceuticals and B iologics. GMP Contracting, Inc. Matt Bestercy (631) 838-9083 mbestercy@bestgmp.net. We help you decide what to validate using sound, documented scientific rationale. We leverage commissioning activities to avoid duplication of testing under qualification. Only systems having direct product quality impact are qualified. All other systems are properly commissioned. Our validation experience is broad:. Packaging Equipment and Line Qualifications.

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Technical Training

http://www.bestgmp.net/technical-training.html

Technical Services for Manufacturers of Pharmaceuticals and B iologics. GMP Contracting, Inc. Matt Bestercy (631) 838-9083 mbestercy@bestgmp.net. Using traditionally accepted methods such as ADDIE, we will analyze customer's needs and develop the appropriate solution to meet those needs. We create valid and reliable technical training materials that are cGMP compliant. Employee qualifications are confirmed through the use of knowledge and skills assessments.

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Recent Projects

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Technical Services for Manufacturers of Pharmaceuticals and B iologics. GMP Contracting, Inc. 631) 838-9083 mbestercy@bestgmp.net. Mid-Size Rx Drug Product Manufacturer, New Jersey (2011-2013). Warning Letter Remediation -. Cleaning Validation: Preparation of Master Plan, including Matrix Scheme. Drafted sampling plans, including MAC acceptance criteria. Process Validation: PV program Gap Assessment and remediation. Packaging Validation: Drafted Master Plan, Gap Assessment and remediation. Remediation pr...

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Compliance Improvement

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FMEA's and Mitigation Plans. Technical Services for Manufacturers of Pharmaceuticals and B iologics. GMP Contracting, Inc. 631) 838-9083 mbestercy@bestgmp.net.

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Process Validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting it's predetermined specifications and quality characteristics.". FDA Guideline on General Principles of Process Validation. Technical Services for Manufacturers of Pharmaceuticals and B iologics. GMP Contracting, Inc. To support Good Manufacturing Practices by always focusing on the guidelines, ensuring the ultimate goal - patient safety.

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