article thumbnail

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.

article thumbnail

Beyond instruments: streamlining process technology implementation in biopharmaceutical manufacturing

European Pharmaceutical Review

To give examples, such a work package focuses on the identification of regulations (ICH Q2 R2, 3 Q8-Q14, 4-10 FDA PAT guidance, 11 EMA Annex 15 12 ), some of which may be mainly guidance documents with recommendations and flexibility when it comes to PAT.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

NHC Submits Comments on CMS’ Proposed Rule on Marketplace Integrity and Affordability

Putting Patients First Blog

The proposal to eliminate the automatic 60-day extension for providing income verification documentation could result in disenrollment of eligible individuals unable to promptly produce required documentation. 22 ,23 Ultimately, these costs are absorbed by local hospitals, health care systems, and state and local governments.

article thumbnail

Addressing US FDA challenges in Indian sterile drug manufacturing – Part 3

Express Pharma

Archive design basis documents for all facility, process, and utility decisions. Treat each deviation, complaint, or EM excursion as a rehearsal for an FDA discussion – document decisions, risk rationales, and CAPAs with inspection-grade clarity. Regularly conduct mock inspections using external or cross-site auditors.

article thumbnail

The Value of a Medically Integrated Pharmacy to Maximize Cost Avoidance and Reduce Waste of Oral Oncolytic Medications

Pharmacy Times

The National Institutes of Health reports that in 2012, $418 billion was wasted in the US due to suboptimal use of medications. During this time frame, the pharmacy documented 152 interventions. compared with $546,082.45 for the external mail-order pharmacies. Withholding shipment saved $1.9 million in cost avoidance.

article thumbnail

Regulating decentralised manufacturing in the UK – a legal perspective

European Pharmaceutical Review

Master file the manufacturing dossier in which the main regulatory documents are collected and to which all subordinate sites refer. Available from: [link] Human Medicines Regulations 2012 and Medicines for Human Use (Clinical Trials) Regulations 2004. One file per product. Internet] UK Government. Under the Human Tissue Act 2004.

article thumbnail

Medication Counselling

RX Note

The document is divided into two main sections: Drug Class/Active Ingredients - covering common classes of chronic disease medications. Notably, all disease-specific discussions have been removed. This ensures that the guideline's recommendations are less likely to be affected by evolving clinical management strategies.