$162
PDA TR 73-2
2024
Technical Report No. 73-2 (TR 73-2) Application of Medical Device Regulation Annex I Requirements for Staked Needle Syringes
- Format:
- Language(s) :
- Published :
- English
- 02/06/2024
As a result of the COVID-19 pandemic, many industries-the pharmaceutical included-went through a substantial disruption.Some of these disruptions included facility shutdowns, unprecedented supply chain challanges, worker availabitlity, and quality system limitations (e.g. physical signatures, investigations, document originals, risk assessments, audits.) For many pharmaceutical companies, challanges increased as they raced to provide a vaccine or a therapeutic treatment for COVID-19. Their manufacturing operations were changed over to accommodate the creation of the vaccine and, in order to get the vaccine to patients quickly, many logistical challanges arose.
This document provides lessons learned from the COVID-19 pandemic to pharmaceutical manufacturing. Areas covered include manufacturing, people, quality, regulatory and supply chain.
| PDA TR 73-2 | |
|---|---|
| STANDARD INFO: | |
| Standard Name | PDA TR 73-2 |
| Scope | Technical Report No. 73-2 (TR 73-2) Application of Medical Device Regulation Annex I Requirements for Staked Needle Syringes |
| Publisher | PDA - Parenteral Drug Association |
| Languages | English |
| State | |
| Publication Year | 2024 |
| Most recent Version | MOST RECENT |
| Whether to be replaced | |
| Addendum | |
| FILE INFO: | |
| File Size | 1 file , 810 KB |
| ISBN(s) | 9781945584442 |
| Number of Pages | 41 |
| Published | 02/06/2024 |
| PDA TR 73-2 | ||
|---|---|---|
| History | Publisher Year | |
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