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cGMP AUDIT SERVICES FOR FOREIGN ESTABLISHMENTS SUBJECT TO PENDING U. S. FDA OFFICIAL RIGOROUS QC REGULATORY FACILITY FIELD INSPECTIONS AUDITS
cGMP AUDIT REGULATORY AFFAIRS SERVICE:
(Fee varies, please submit inquires for fee estimate quotation as selected from the following)-  Click here to contact one of our Representatives.

1. Design and Install Effective Quality Assurance Systems and Procedures
2. Conducting cGMP, Quality System and pre-approval regulatory audits of     manufacturers and vendors to assure FDA compliance with current requirements.
3. Conducting mock FDA audits to prepare for pre-approval regulatory inspection.
   Develop and Implement a Set of Corporate Written Policies and Procedures on issues pertaining to Governing Inspections, and Formulating Written Corporate Positions on Potentially Controversial Issues
4. Interpretation of FDA policy and guidance for product submission evaluation,   review and current Good Manufacturing Practices (cGMPs).
5. Conducting Good Clinical Practice (GCP) audits of ongoing clinical studies and trials.
6. Assure that the conduct of due diligence audits make the basis for informed    management decisions in marketing.
7. Implemented an Internal Audit Program to ensure that the desired results are  being obtained on an ongoing basis.
8. Maintain Secure Record Keeping Practice and Organize Records Appropriate for Review and Delivery to Regulatory Inspector along with product samples.
9. Perform Part 11 Electronic Signature system audits to ensure that electronic    records and recordkeeping comply with FDA regulations (eCTD).
10. Designate and Train Owner/Managers and Inspection Coordinators to serve as hosts at each facility and Make Arrangements to Guarantee that FDA Regulatory Inspectors will be Courteously Received and Adequately looked after during their visits.
11. Appropriate Follow-Up Actions to be taken at the conclusion of each visit and Analyze the Results of each inspection to determine how the program can be strengthened for the future.

AGDE Corp.’s “STRATEGIC REGULATORY CMC” Service Includes:
(Fee varies, please submit inquires for fee estimate quotation as selected from the following):-
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“STRATEGIC REGULATORY CMC COMPLIANCE SERVICE”, Chemistry, Manufacturing and Controls (CMC) audits which certify that drug producing facilities adheres to proper drafted CMC Section and implemented a cGMP/QA/QC program that represents good manufacturing system and management practices with assistance from our “Independent cGMPAudit Regulatory Affairs Team”, and will also conduct CMC (and API Manufacturing Quality System) Controls Review and Assessment Audits to include but may not be limited to the following:

1. Assistance in defining application strategies and preparation of the Chemistry and Manufacturing Controls (CMC) Section of New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), New Animal Drug Applications (NADAs), Drug Master Files (DMFs) and Investigational New Drug Exemption (INDs) application filings.
2. Assistance in communicating with FDA and preparing for CMC meetings with agency officials on application issues.
3. Conducting on-site custom seminars to strengthen the CMC regulatory knowledge level of management and applicable staff personnel.
4. Delivery of formal seminars and training conferences where appropriate
5. Consultation services providing strategic intelligence from various regulatory agencies.
6. Drafting manufacturers’ standard procedures for product recalls, complaint handling, failure investigations, change controls and other quality functions.
7. Initiating, coordinating, and participating in meetings with FDA or EU regulatory authorities to resolve regulatory issues resulting from review of a submission or a voluntary compliance action.
8. Review of product labeling and user instructions to assure materials adhere to FDA policy and domestic import requirements

AGDE Corp.’s “STRATEGIC REGULATORY API’s” Service Includes:
(Fee varies, please submit inquires for fee estimate quotation as selected from the following):-
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“STRATEGIC REGULATORY API’s COMPLIANCE SERVICE”, Active Pharmaceutical Ingredients (API’s) audits which certify that API producing facilities adheres to proper drafted API QS Processes and implemented a cGMP/QA/QC program that represents good manufacturing system and management practices acceptable to FDA regulatory inspection requirements and what constitutes cGMPs for APIs, FDA has adopted as part of the Compliance Program an internationally harmonized guidance, “ICH Q7A while adapting some current “science-based” policies and is essential to the Compliance Program for Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.” Developed under the auspices of the International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use and which specifically addresses the distinctive attributes of API processes. With assistance from our “Independent cGMP Audit Regulatory Affairs Team”, we will also conduct API Quality System Review and Assessment Audits to include but may not be limited to the following

1.Quality System: The Quality System assures overall compliance with cGMPs and a
company’s internal procedures and specification.
   
PHASE I: First, our “Independent Auditor” will evaluate whether the Quality Unit
has fulfilled its responsibility to review and approve all procedures related to production, quality assurance, and quality controls and whether the procedures are adequate to fulfill their stated purpose, including associated record-keeping systems.      
PHASE II: Second, our “Independent Auditor” will assess the data collected pursuant to these specified procedures to identify quality problems.

2.Facilities and Equipment System: The Facilities and Equipment System comprises the physical environment and resources used to produce APIs.

3.Materials System: The Materials System includes the mechanisms by which starting materials, intermediates, and containers are controlled, including validation of computerized control processes, storage, and distribution controls.

4.Production System: The Production System is the scheme for controlling the manufacture of APIs; this includes in process sampling/testing and process validation.

5.Packaging and Labeling System: The Packaging and Labeling System consists of
elements that control the packaging and labeling of intermediates and APIs.

6.Laboratory Control System: The Laboratory Control System is the system used to direct laboratory procedures, testing, analytical methods development, and methods validation or verification, as well as the stability program.
 

Other FDA Considerations:
Procedures and Data regarding:

• The adequacy of staffing, as well as the training and qualification of employees in quality control functions;
• The conduct of periodic quality reviews and complaint reviews;
  Any discrepancy and failure investigations related to manufacturing and testing;
• Batches manufactured since last inspection (to appraise any rejections or     conversions);
• Change control; returns and salvages; rejects; reprocessing/reworking events;

Recalls;

• The system for raw material release; stability failures; and the status of validation activities