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FDA/CGMP Key Steps for Compliance


Step 1
Prepare FDA/CGMP Implementation Plan and Detailed Schedule Accelerate & Clients
+ Prepare plan for the FDA/CGMP Quality System Development
(Accelerate will work with Client)
Step 2
Gap Assessment FDA/CGMP
+ Perform the FDA/CGMP Gap Assessment to Identify GAPS between the standard and what exist.
(Accelerate will prepare the report)
Step 3
FDA/CGMP Training (Auditors)
+ Train the FDA/CGMP Internal Auditors and Process Owners to the Standard.
Upon passing the exam, process owner taking training will get qualified as Internal Auditor
and Lead Auditor Accelerate will issue certificate.
Step 4
FDA/CGMP Implementation Training
+ Train process owners to FDA/CGMP Implementation Process.
(Accelerate will perform the activity)
ISO will issue certificate on passing exam.
Step 5
FDA/CGMP Quality Policy (Define & Document)
Accelerate & Client
+ Define FDA/CGMP Quality Policy to internal and external customers.
(Accelerate will prepare Quality Policy working with Client
Step 6
Quality Objectives for FDA/CGMP
(Define & Document)
Accelerate & Client
+ Define FDA/CGMP Quality Objective with reference to Quality Policy.
(Accelerate will prepare working with Client)
Step 7
Measurement Analysis & Improvement for FDA/CGMP
(Define & Document)
+ Define FDA/CGMP Measurement Analysis Process for continuous improvement.
(Accelerate will prepare working with Client)
Step 8
FDA/CGMP Quality Planning (Define & Document)
+ Define FDA/CGMP Quality Planning Process.
(Accelerate will prepare working with Client)
Step 9
FDA/CGMP Executive Management Training
+ Train FDA/CGMP Executive Management for the process for Conducting Management Review.
(Accelerate will issue certificate)
Step 10
Documentation of Data Control for FDA/CGMP

Hazard Analysis and Risk Assessment
-Development of a consistent
approval process

+ Define FDA/CGMP Documentation and Data Control Process for development
and Management of Documentation Control System.
(Accelerate will develop, works with Client, which include infrastructure for Documentation Control)
Step 11
Level I (Quality Manual for FDA/CGMP)
+ Prepare FDA/CGMP Quality Manual.
Document the Company Policy in the manual for compliance to the standard.
(Accelerate will prepare for Client)
Step 12
Level II (Standard Operating Procedures for FDA/CGMP)
+ Define the process and the interaction between the processes.
Document each process in compliance with the standard.
(Accelerate will prepare with Client)
Step 13
Level III (Work Instructions for FDA/CGMP) Draft
Accelerate & Client
+ FDA/CGMP Document the processes in detail if needed.
(Accelerate will work with Client)
Step 14
Level I (Quality Manual for FDA/CGMP)
Approval/Sign-Off Client
+ Have Top Management sign the FDA/CGMP Quality Manual.
(Client works with Accelerate)
Step 15
Level II (SOP for FDA/CGMP)
Client & Accelerate
+ Have all FDA/CGMP procedures approved by process owners and concerned functions.
(Client works with Accelerate)
Step 16
Level III (Work Instructions)
Client & Accelerate
+ Have work instruction signed-off by concerned functions.
(Client works with Accelerate)
Step 17
First FDA/CGMP Internal Audit (by qualified Internal Auditors) Client & Accelerate
+ Perform first FDA/CGMP Internal Audit. This audit will be conducted by independent Internal Certified Auditors. (Client will perform with support from Accelerate)
Step 18
FDA/CGMP Corrective & Preventive Actions, customer, vendor, quality Client & Accelerate
+ Do close loop FDA/CGMP corrective and preventive action for all issues including issues from Internal Audit (STEP 17). (Client will perform with  Accelerate)
Step 19
FDA/CGMP First Management Review (Performed by Management Rep. & Executive Mgmt.)
+ Conduct FDA/CGMP Management Review as per Management Review procedures. (Client works with Accelerate)
Step 20
Second Internal Audit (By Qualified Internal Auditors)
Accelerate & Client
+ Perform second Internal by Certified Internal Auditors (same as STEP 17). (Client works with Accelerate)
Step 21
Corrective & Preventive Action for 2nd Internal Audit
Accelerate & Client
+ Perform close loop corrective and preventive action (Same as STEP 18). (Client works with Accelerate)
Step 22
Second Management Review (By Executive Mgmt.) Client & Accelerate
+ Perform Management Review as per Management Review Procedure (same as STEP 19).
(Client works with Accelerate)
Step 23
Registrar Pre-Assessment (Optional Activity) Registrar Client & Accelerate
+ Registrar (an independent certifying body) to perform Pre-Assessment (Accelerate will support)
Step 24
FDA/CGMP Corrective & Preventive Actions to registrar finding Accelerate & Client
+ Do close loop FDA/CGMP corrective actions (same as STEP 18 & 21) (Client works with Accelerate)
Step 25
Accelerate Documentation Review
+ Accelerate Review the complete system for compliance to standard.
Step 26
Accelerate Assessment
+ Accelerate perform audit for identifying issues to related Implementation.
Step 27
Corrective & Preventive Actions
+ Do close loop corrective & preventive action for all issues raised (STEP 25 & 26)(Accelerate works with Client)
Step 28
Final Audit for Compliance
(Accelerate will support)
Step 29
Prepare action plan
+ Submit Action Plan & close Registrar Findings.. (Accelerate works with Client)
Step 30
Client Compliance
Project complete
Step 31
FDA/CGMP Maintaining Upgrade & Training
+ Accelerate will provide. (If desired)

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