Parenteral Drug Association Releases New Report on Manual Aseptic Processes - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Parenteral Drug Association Releases New Report on Manual Aseptic Processes


The Parenteral Drug Association (PDA) released “Technical Report No. 62 (TR 62), Recommended Practices for Manual Aseptic Processes,” the association announced in a press release. The purpose of TR 62 is to outline methods and approaches for control and evaluation of aseptic processing operations for drug or medicinal products that use all or partially manual procedures.

TR 62 has value for hospital and formulation pharmacies where manual aseptic processing may occur. The guidance provided in this report may be applicable to operations including: vaccine preparation, cell culture, gene therapy, investigational new drug or medicinal product manufacturing, clinical and commercial manufacturing, and pharmacy formulation and dispensing. TR 62 is not intended to address the brief, relatively infrequent, human interventions into an otherwise automated filling process. Examples include reach-ins to remove a toppled vial from the filling line or to obtain a container for a fill-weight check, aseptic connections made during set-up, and corrective activities during line stoppages.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
24%
Attracting a skilled workforce
30%
Obtaining/maintaining adequate financing
15%
Regulatory compliance
30%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans

Click here