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
cGMP Guidance: Sterile Drug Products Produced by Aseptic Processing
- By: Staff Editor
- Date: November 30, 2016
- Source: http://www.fda.gov/
cGMP Guidance: Sterile Drug Products Produced by Aseptic Processing
This guidance is proposed to aid manufacturers of sterile drug and biological products meet the FDA cGMP requirements when manufacturing these products under aseptic processing. This guidance replaces the 1987 Industry Guideline on Sterile Drug Products Produced by Aseptic Processing.
For sterile drug products that are subjected to a new or abbreviated drug application (NDA or ANDA) or a biologic license application (BLA), this guidance document should be used in conjunction with the guidance entitled Guideline for the Submission of Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products.
This guidance document does not address all aspects of aseptic processing. Although it explains CGMP issues relating to the sterilization of components, containers, and closures, terminal sterilization of drug products is not discussed.
Summary of Requirements
The Guidance details the requirements for:
- Building and Facilities: This includes requirements for critical areas-Class 100, supporting clean areas, clean area separation, air filtration and design of the aseptic area
- Personnel training, qualification and monitoring
- Preparation and inspection of containers/closures
- Establishing endotoxin control
- Time limitation for each phase of the aseptic processing
- Validation of aseptic processing and sterilization
- Laboratory controls including environmental monitoring, microbiological media and identification, prefiltration bioburden, alternate microbiological test methods and practical monitoring.
- Sterility testing including microbiological controls, sampling and incubation, and investigation of sterility positives
- Review of all the batch records and process control documentation
Related Training:
Guideline to Aseptic Technique and Clean Room Behavior

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
