Pharmaceutical Technology

JUNE 15, 2023

Once the target is identified, researchers work to develop a compound that can interact with it. After a promising compound has been identified, it’s tested in preclinical models to evaluate its safety and efficacy. The target could be an enzyme or receptor in the human body, or it could be an organism that causes disease.

Compounding 52

Compounding Adverse Reactions Dosage Documentation 52

ISPE

MARCH 16, 2023

The document provides specific guidance on the sampling and testing procedures for environmental monitoring, as well as the limits for particular and microbial contamination. ISPE Good Practice Guide on Containment for Potent Compounds 4. Environmental monitoring is another important aspect of Annex 1.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Documentation Dosage 98

ISPE

MAY 9, 2023

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

SEPTEMBER 11, 2023

Examples include platforms as small as autonomous units placed within a facility and mobile production trailers for compounding to platforms as large as a prefabricated, self-contained GMP facility. POD is suitable for a wide range of products, including oral solid dosage forms, mAbs, and cell therapy. Nature Communications 12, no.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

AUGUST 30, 2022

With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. Health authorities have divergent classifications for changes in terms of risk to product quality and documentation/data requirements. Burke, PhD. 1 September 2022.

Documentation 52

Documentation FDA Packaging Communication 52