ISPE

AUGUST 15, 2023

We will introduce a visionary approach to develop a Contamination Control Strategy (CCS) for ATMPs based on Holistic Risk Assessment. This development should consider all the risks associated with each process and have a well-defined plan to manage those risks based on data. ™ QbD Regulatory With some focus on Pharma 4.0™,

Documentation 52

Documentation Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

NOVEMBER 10, 2022

Why QbD and Digitalization Are Foundations for Cell Therapies. Why QbD and Digitalization Are Foundations for Cell Therapies. Digitalization is thus vital for us to enable QbD and continuous monitoring. Trudy Patterson. Thu, 11/10/2022 - 14:00. Online Exclusives. November / December 2022. David Margetts. 10 November 2022.

Documentation 98

Documentation Compounding Hospitals Immunization 98

European Pharmaceutical Review

NOVEMBER 16, 2022

As the emphasis of new drug development gravitates towards new, ground-breaking therapies and vaccines, the requirements of manufacturing sites, equipment and processes need to be appropriate for this new environment.

Documentation 114

Documentation Vaccines 114

European Pharmaceutical Review

SEPTEMBER 20, 2023

Although this evolution has led to life-changing medications, it also calls on drug development and manufacturing experts to identify new, more efficient ways to deliver high‑quality products. Pharmaceutical development is driven by quality by design (QbD) – an approach recommended by regulatory agencies.

85

85

European Pharmaceutical Review

MARCH 1, 2023

Importance of CT in pharmacy Industrial CT is an established method for reliable product and process development, process monitoring and requalification. While traditional optical methods can only assess the surface, X-ray technology can be used to display the internal structure, and thus may detect defects and deviations in geometry.

Dosage 87

Dosage 87

ISPE

MAY 11, 2023

is that validating a process is demonstrating that the control strategy is in place and effective using quality by design (QbD), knowledge management (KM), and risk management (RM) principles. approach aims to validate a process by demonstrating the control strategy is in place and effective using QbD, KM, and RM principles.

Documentation 52

Documentation Labelling FDA 52

Pharmaceutical Technology

JULY 18, 2022

With the ever-rising costs of bringing a drug to market, pharmaceutical companies are increasingly looking at how they can improve the efficiency of their entire product development and drug commercialisation process. There is a risk for variation between batches.”.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Dosage Communication 52

European Pharmaceutical Review

NOVEMBER 9, 2022

Traditionally, companies have sought to outsource the development and manufacture of vectors to a contract development and manufacturing organisation (CDMO). To integrate vector supply, upfront challenges and costs include developing a scalable process and setting up a good manufacturing practice (GMP) manufacturing facility.

Vaccines 99

Vaccines Documentation Communication Hospitals 99

ISPE

JULY 10, 2023

We structure the rest of our article as follows: We provide an overview of how LLMs operate and how ChatGPT was constructed, describe use cases of ChatGPT as an example of generative AI that is optimized for chatting, and present use cases ranging from the original idea of chatting and text creation to software development.

Labelling 52

Labelling Documentation Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

MARCH 8, 2023

On Developing a Process for Conducting Extractable–Leachable Assessment of Components Used for Storage of Biopharmaceuticals.” It is also in line with the mission of PIC/S to lead in the international development, implementation and maintenance of harmonized GMP standards. 3 December 2021. link] 30 a b c Wakankar, A. Canova-Davis, S.

Compounding 52

Compounding Compounding Pharmacies Packaging FDA 52

ISPE

JULY 6, 2023

The risk appetite statement should in turn be driven to each line of business with key risk indicators (KRIs) developed for important risks to be managed for that year. At the business unit level, the risk appetite approach could be leveraged in product development and new initiatives such as manufacturing technology investments.

Insurance 52

Insurance Documentation Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

JULY 6, 2023

2 CM can integrate with the PAT and quality by design (QbD) approaches of manufacturing that are capable of increasing the efficiency, flexibility, agility, and robustness of pharmaceutical manufacturing. This will ultimately improve productivity, efficiency, and the quality of the final product using a QbD approach to manufacturing.

HIV Treatment and Prevention Agents 52

HIV Treatment and Prevention Agents Dosage Pharmaceutical Companies 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. McQueen Nina S. ™ technologies.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

MARCH 29, 2023

This structure does not allow explanation of justification for the control strategy, 2 particularly when a quality by design (QbD) approach is employed. 6 Based on the framework that was developed by the PhRMA team, Pfizer piloted an approach to Module 2 that was referred to as the “comprehensive Quality Overall Summary (QOS).”

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

This structure does not allow explanation of justification for the control strategy, 2 particularly when a quality by design (QbD) approach is employed. 6 Based on the framework that was developed by the PhRMA team, Pfizer piloted an approach to Module 2 that was referred to as the “comprehensive Quality Overall Summary (QOS).”

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

FEBRUARY 15, 2023

ICH has the mission “to achieve greater harmonization worldwide to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner.” Harmonization of global regulatory requirements has been progressing for more than thirty years under the International Council for Harmonisation (ICH).

Dosage 95

Dosage FDA 95

ISPE

SEPTEMBER 8, 2023

This ISPE team developed a comprehensive survey, with the objective of gathering data on the specific origins, extent, and magnitude of the challenges and barriers that limit or reduce the development and implementation of innovative technologies. The survey launched in April 2023 and is still open !

FDA 52

FDA Dosage Documentation Communication 52

Pharmaceutical Technology

JANUARY 6, 2023

It requires having access to proper techniques and skill sets, state-of-the-art equipment, process scientists and engineers who have a deep understanding of Quality by Design (QbD) principles, and methods for product and process characterisation. Optimising development and scale-up. Particle distribution. Grittiness.

Dosage 52

Dosage Packaging Communication 52