GMPSOP

APRIL 3, 2023

In other word, you need GMP documentation specially developed and used for your laboratory to guide you through everything you do in the lab. Depending on the objective of the lab, the need for GMP documentation will change for the laboratory. The significance of well-designed GMP documentations is immense.

Documentation 52

Documentation Method Validation Compounding Data Entry 52

GMPSOP

OCTOBER 28, 2023

The analyst should ensure that the supervisor is notified as soon as an OOS event occurs, the sample is retained, and a documented investigation is commenced. – Document control records management and archiving systems. Additional documents included each month. All written and updated by GMP experts.

Documentation 52

Documentation Method Validation Packaging Data Entry 52

pharmaphorum

OCTOBER 6, 2020

To improve data confidence regulatory executives should take a four-step approach to change how they: Collect Data: Life sciences organisations should utilise cloud-based solutions with global access that facilitates one repository with a single source of truth and eliminates the use of local file sharing and servers.

Documentation 114

Documentation Communication Labelling Data Entry 114

GMPSOP

JULY 31, 2023

The data entry and retrieval process, user access and security, electronic signature, audit trail, system integration, performance, printing, etc. These requirements mandate that pharmaceutical companies thoroughly document OQ protocols, testing methods, acceptance criteria, and results. 90% to 110% of the label claim).

Documentation 52

Documentation Dosage Labelling Data Entry 52

Pharmaceutical Technology

SEPTEMBER 7, 2022

AEs can be caused by using medicinal products within or outside the terms of their marketing authorisations (such as off-label therapeutic use, overdose, misuse, abuse or medication errors), as well as from occupational exposure.

Data Entry 52

Data Entry Vaccines Documentation Labelling 52