ISPE

JUNE 26, 2023

The Process Analytical Technology (PAT) concept can thus be fully realized. The ICH Guidelines were referred to as a basis, for example, the need for management oversight as given in ICH Q10 (Pharmaceutical Quality System) as well as ICHQ3 (continuous manufacturing), which requires large amounts of data for monitoring.

FDA 97

FDA 97

pharmaphorum

DECEMBER 16, 2022

Instead, take your children out for a fun day at the theme park, volunteer at the local soup kitchen, spend quality time with your parents, have friends over for New Year’s Eve, or enjoy dinner with your spouse. Appreciate strong partners.

Communication 98

Communication 98

European Pharmaceutical Review

JULY 28, 2023

A research paper has reported a practical framework suitable for a systematic step-by-step quality by design (QbD) approach for the pharmaceutical development of bilayer tablets. Applying quality by design (QbD) to bilayer tablet development QbD is a concept that is being increasingly adopted in pharma. Ultimately, Simão et al.

Dosage 98

Dosage 98

European Pharmaceutical Review

FEBRUARY 7, 2024

The authors summarised that a “truly effective process analytical technology (PAT) strategy requires the seamless interplay of reliable in-line sensors and instruments to enable real-time measurements and establishment of a robust digital environment to securely manage the flux of data generated.”

78

78

ISPE

JULY 6, 2023

Q13 Scope The intent of Q13 is to build on existing ICH quality guidelines while providing clarification on CM concepts. A key thrust of the guidance is to highlight when concepts that are unique to CM need to be part of the regulatory filing versus appropriately captured within each companies’ pharmaceutical quality system (PQS).

Documentation 52

Documentation Dosage FDA Pharmaceutical Companies 52

ISPE

SEPTEMBER 11, 2023

Cauchon, PhD 1 September 2023 The biopharmaceutical industry must develop and implement innovative ways of working to be effective and efficient in the current healthcare ecosystem, in which high-quality medicines, adaptability, and assurance of supply are of critical importance. ™ technologies.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

JULY 5, 2023

In 2014, CDER established the Emerging Technology Program (ETP) within its Office of Pharmaceutical Quality to better facilitate the adoption of emerging technologies such as CM. 13 An FDA-authored paper indicating support for the implementation of CM using science- and risk-based approaches followed soon thereafter.

FDA 52

FDA Dosage Documentation Pharmaceutical Companies 52

ISPE

OCTOBER 28, 2022

Highlights from several plenary sessions and keynotes are provided here; the sidebar addresses a panel discussion about addressing risk management as biopharmaceuticals continue to move forward. This was not without risk; as Andres noted, risk management is essential to the work of building a new class of medicine.

Vaccines 52

Vaccines FDA Immunization 52

ISPE

JULY 6, 2023

This article provides a review on the current state of CM implementation, offers insights into life cycle management and regulatory aspects, and explains how a data- and knowledge-centric approach to risk management can help CM achieve its full potential. 10 Table 2: CM advantages. 10 Table 2: CM advantages. 10 Table 2: CM advantages.

HIV Treatment and Prevention Agents 52

HIV Treatment and Prevention Agents Dosage Pharmaceutical Companies Pharmaceutical Companies 52

Pharmaceutical Technology

JUNE 26, 2022

This minimizes downstream risks, helps to determine a suitable synthetic route for scale-up, and facilitates an easier transition into the formulation development phase. PAT enables us to make use of software and artificial intelligence (AI) as a predictive control tool. Important considerations for drug substance development.

Compounding 52

Compounding Pharmaceutical Companies Pharmaceutical Companies Communication 52

Pharmaceutical Technology

APRIL 12, 2023

Evidence suggests that API manufacturing is gaining in complexity, as well as sophistication, and therefore adding to the risk profile of drug development. The ingredients used in these drugs are high potency, even at small doses, and pose a risk to both human health and cross-contamination with other drugs in a manufacturing environment.

Controlled Substances 52

Controlled Substances Dosage Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

MARCH 15, 2023

Following inspiration from such initiatives as PAT and Pharma 5.0, Daylighting via high-level windows and light shelves re-directing is the most sustainable source, but is sometimes obviated by reasons of layout, security, and product quality. many facilities are becoming more intelligent and automated.

Packaging 52

Packaging Labelling Health Compliance Process Improvement 52