Your Shopping Cart
By using this site you agree to our use of cookies. Please refer to our privacy policy for more information. Close
Hello. Sign In
Your Account

Log In to ComplianceOnline
Welcome back! Please log in below to continue.
0
Cart
Toll Free:
+1-888-717-2436
+1-888-717-2436
Industries
- Banking & Financial Services
- BANKING & FINANCIAL SERVICES
- Banks and Credit Unions
- Financial Services and Trading
- Insurance
- Accounting and Taxation
- Life Sciences
- Hitech, Aero & Manufacturing
- HITECH, AERO & MANUFACTURING
- Quality & Safety
- Standards and Methodology
- Energy & Utilities
- ENERGY & UTILITIES
- IT Security
- Reliability (NERC / FERC)
- Quality and Safety
- Risk Management
- CPG & Retail
- CPG & RETAIL
- Retail Audit
- Quality & Safety
- Social Compliance
- Healthcare
- Food & Dietary Supplements
- Cross Industry Functions
Webinars
By Industries
Seminars
Quality Control Laboratory Compliance - cGMPs and GLPs
Process Validation Guidance Requirements (FDA and EU Annex 15: ...
FDA Recalls - Before You Start, and After You Finish
Biostatistics for the Non-Statistician
Data Integrity: FDA/EU Requirements and Implementation
Managing Domestic and Foreign FDA Inspections and the ...
Recordkeeping and Documentation in a GLP Laboratory ...
Reduce costs for compliance with data integrity: 21 CFR Part 11 ...
Change Control Best Practices - Avoiding Unintended ...
Technical Writing for Pharma, Biotech and Medical Devices
Standards
Aerospace
Agriculture and Farm Machinery
Automotive, Aircraft & Marine technology
Banking, Corp. finance & Sox
Biotech & Pharmaceutical Standards
Chemical technology
Civil engineering and construction
Computer Hardware
Electrical Engineering
Electronic Equipment
ANSI
Audit Net
BIN
BPA
Business Basics
Complianceonline
IT Governance
LabCompliance
Quality-Control-Plan
RCGLOBAL
SHOQ Quality Assurance Manuals
SEPT
Home
› Best Practices
FDA Guidance on cGMP Requirements for Combination Products
- By: Staff Editor
- Date: February 02, 2017
- Source: http://www.fda.gov
FDA Guidance on cGMP Requirements for Combination Products
The US regulatory pathway for combination products is not always very clear. As combination products include constituents that would normally be regulated under different types of governing authorities, they raise regulatory, policy, and review management challenges.
US FDA has recently issued a final guidance detailing the cGMP requirements for combination products including drug-drug, drug-device, device-biologic or drug-biologic combination products. The guidance follows the 2013 final rule on cGMP requirements for combination products.
Related Training:
Navigating the new FDA World of Combination Products
GMP Requirements for Combination Products for the Medical Products Industry
Summary of Requirements
Key topics addressed in the guidance includes:
- Overview of the 2013 final rule on CGMP requirements that apply to each of the constituent parts of the combination products.
- Role of the lead centre and other Agency components.
- Definitions and meaning of various terms related to combination products including manufacture, manufacturer, constituent part and component, device, container, closure and convenience kit.
- cGMP requirements that apply to a product or a facility.
- Provisions from the device QS regulations including management responsibility, design controls, purchasing controls and corrective and preventive actions (CAPA).
- Provisions from the drug cGMPs including:
- testing and approval or rejection of drug product components, containers, and closures
- Calculation of yield
- Tamper-evident packaging requirements for OTC human drug products
- Expiration dating
- Testing and release for distribution
- Stability testing
- Special testing requirements
- Reverse Samples
- Combination products that include biological products and Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps).
- Application of cGMP requirements to special type of products including prefilled syringe, drug-coated mesh and Drug Eluting Stent (DES).
The guidance document also covers hypothetical scenarios that explain how to comply with certain cGMP requirements for specific types of combination products.

Compliance Trainings

Pregnancy in the Workplace: Strategies to Protect Your Organization from Pregnancy Discrimination Claims
By - Christopher W. Olmsted
On Demand Access Anytime
By - Christopher W. Olmsted
On Demand Access Anytime

How to Vet an IRB: Expose and Fix Problems Before They Threaten Your Trial
By - Madhavi Diwanji
On Demand Access Anytime
By - Madhavi Diwanji
On Demand Access Anytime

Compliance Standards
Best Sellers
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
-
By: Miles HutchinsonAdd to CartPrice: $249
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
-
San Francisco, CA | Aug 6-7, 2020
-
Virtual Seminar | Jul 16-17, 2020
-
Virtual Seminar | Jun 18-19, 2020
-
Los Angeles, CA | Aug 20-21, 2020
-
Virtual Seminar | Jul 16-17, 2020
-
Virtual Seminar | Jun 25-26, 2020
-
Virtual Seminar | Jun 10, 2020
-
Virtual Seminar | Jun 3-4, 2020
-
Virtual Seminar | Jul 6-7, 2020
-
San Francisco, CA | Oct 22-23, 2020
-
Virtual Seminar | Jul 9-10, 2020
-
Virtual Seminar | Jun 3-4, 2020
-
Virtual Seminar | June 3-4, 2020
-
Miami, FL | Jul 29-31, 2020
-
Virtual Seminar | Jun 17, 2020
-
Provider: ANSIAdd to CartPrice: $142
- Add to Cart
- Add to Cart
- Add to Cart
-
Provider: ANSIAdd to CartPrice: $120
-
Provider: ANSIAdd to CartPrice: $250
-
Provider: SEPTAdd to CartPrice: $299
- Add to Cart
-
Provider: Quality-Control-PlanAdd to CartPrice: $37
- Add to Cart
-
Provider: At-PQCAdd to CartPrice: $397
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
You Recently Viewed
