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The Saffron book: An orange book of India

Express Pharma

FDA’s  Orange Book  can serve as a reference point—with the aim of building an even better version. The differences between SUGAM and intended Saffron Book which is customised version of U.S. Orange book are listed below. FDA’s  Orange Book. What Is the Orange Book and why is it important?  

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The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

FDA Law Blog: Biosimilars

OGDP is one of several offices in OGD, and it was composed of three divisions: the Division of Legal and Regulatory Support, the Division of Orange Book Publication and Regulatory Assessment, and the Division of Policy Development (DPD). Providing significant policy support to the annual update of the Orange Book Preface.

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FOPE & PharmaState Academy hosts session 15 PULSE Program

Express Pharma

He explained the difference between incidents and deviations, stating that deviations are departures from written procedures, while incidents are unplanned events, reinforcing the need for clear SOPs and proper documentation. For inquiries or to pre-book participation, visit PharmaState Academy’s official website.

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Session 14 of FOPE & PharmaState Academy’s PULSE Program explores investigations & CAPA under Revised Schedule M

Express Pharma

Emphasising a proactive rather than reactive approach, she urged organisations to mitigate risks through thorough root cause analysis (RCA) and systematic documentation. For inquiries or to pre-book participation, visit PharmaState Academy’s official website.

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FOPE, PharmaState Academy, complete one year of the PULSE program

Express Pharma

He noted frequent gaps in team understanding due to staff turnover and stressed the need for strong communication, confidentiality, and documentation practices. Emphasis was placed on treating contracts as living documents and aligning all operational actions with documented expectations.

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Session 22 of FOPE, PharmaState Academy’s PULSE Program drives compliance excellence in OSD manufacturing under Revised Schedule M

Express Pharma

Documentation – Ensure thorough, process-aligned SOPs and real-time CAPA management. The panel concluded that a phased, risk-based approach with clear documentation and management commitment is essential for successful compliance, particularly for MSMEs. Equipment – Prioritise automation and system upgrades for quality and efficiency.

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How to Be Successful on Your APPE Rotations?

UWorld | RxPrep

Whether it’s improving patient counseling or mastering SOAP note documentation, goal-setting helps you stay focused and measure progress throughout your APPE rotations pharmacy journey. Document Everything for Self-Evaluation and Career Growth Keep a rotation journal or digital log.