Impact Pharmaceutical Services

JUNE 23, 2023

Simultaneously, the creation and use of an SOP manual around the complexities of the QC system ensure uniformity and compliance. SOPs are written instructions for achieving uniformity in specific functions and ensuring compliance among all individuals responsible for these tasks.

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52

The FDA Law Blog

MAY 23, 2023

Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact. By Sophia R. Gaulkin & Riëtte van Laack — On May 16, the U.S.

Labelling 45

Labelling FDA 45

ISPE

NOVEMBER 1, 2022

QMM encompasses a range of actions including metrics, leadership commitment, culture, sustainable compliance, enhanced pharmaceutical quality systems, continual improvement, and risk management. Future regulation should be pragmatic, proactive, and rewarding. FDA Activities in Support of Quality.

FDA 98

FDA Insurance Chemotherapy Documentation 98

ISPE

JANUARY 9, 2023

Since the publication of the first edition, GAMP ® 5 has been far and away the leading international guidance on GxP computerized systems validation and compliance. It is important to note that CGMPs are minimum requirements. Center for Devices and Radiological Health (CDRH) Compliance Program. 1 US Food and Drug Administration.

Documentation 52

Documentation FDA Communication 52

ISPE

SEPTEMBER 12, 2022

Corporate Regulatory Compliance & Enforcement Advisor. Senior Policy Advisor for the Global Compliance Branch 3. Currently its practice is looser than cGMP requirements, I believe. Corporate Regulatory Compliance & Enforcement Advisor. Corporate Regulatory Compliance & Enforcement Advisor. 2022 PIC/S Chair, Sr.

FDA 52

FDA Documentation Communication 52

ISPE

SEPTEMBER 11, 2023

These technologies also offer a combination of closed, connected process and the centralized control facilitates improved efficiency, safety, and compliance. Pharmaceutical CGMPs for the 21st Century—A Risk-Based Approach: Final Report.” Examples include a closed aseptic filling system, isolator, and robotic arm for aseptic filling.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52