European Pharmaceutical Review

AUGUST 23, 2022

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

FDA 92

FDA Documentation Packaging Labelling 92

pharmaphorum

OCTOBER 12, 2022

Prior to selling drugs or medical products in any country, pharmaceutical companies must prove compliance and gain the regulatory approval required by the country in which the goods will be distributed in. So, with mandates in place, how do manufacturing facilities meet these compliance goals? The dominion of data.

Documentation 105

Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 105

ISPE

MARCH 20, 2023

In order to strengthen the focus on interfaces, a GAMP®5 compatible validation approach was compiled and published as rule VDI 3516 Part 6. This approach also addresses the latest regulatory expectations set by regulatory bodies, such as described in the recent PIC/S PI-041-1 which calls for validated automated data exchange between systems.

Documentation 97

Documentation Communication 97

European Pharmaceutical Review

APRIL 2, 2024

rCR endotoxin testing: method validation For companies manufacturing products solely marketed in Europe…implementation of rCR testing will be slower than rFC testing” In terms of rCR implementation, it should be noted that Ph. Want to learn more about endotoxin testing and validation…? Download our latest report today!

Method Validation 88

Method Validation Medical Schools 88

pharmaphorum

MARCH 2, 2021

So efficiency, compliance, and patient care have been compromised. They help companies improve the quality of their clinical products, reduce the time it takes to get a product to market and ensure compliance with industry standards and regulations. Validation to check forms have been filled in accurately. What is an EDC system?

Patient Care 116

Patient Care FDA 116

European Pharmaceutical Review

SEPTEMBER 12, 2023

Next, a data-driven approach and scientific principles must be used, along with validated methods and processes. As part of The Future of Pharma/Biopharma Analysis 2023 , which took place on 28-29 June 2023, European Pharmaceutical Review ( EPR ) gathered an expert panel to discuss developing a modern contamination control strategy.

Documentation 124

Documentation 124

European Pharmaceutical Review

JANUARY 9, 2024

With the added benefit of Internet-of-Things (IoT)-enabled real-time monitoring, AI can maintain constant compliance with stringent quality standards that tends to data integrity. Another challenge is regulatory compliance, where AI systems must meet stringent requirements for validation of the data used and quality assurance.

FDA 122

FDA 122

The FDA Law Blog

FEBRUARY 9, 2024

For these devices that do not have market authorization and are only used for remote data collection in a clinical investigation, if the sponsor conducts verification and validation activities consistent with the guidance to demonstrate the DHT is “fit-for-purpose,” FDA does not intend to assess sponsors’ compliance with design controls.

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FDA Documentation 105

ISPE

MAY 1, 2023

On a high level, the validation master plan mentioned that the CSV approach had to be compliant with several regulations and standards and also here is was not clear whether this was consistent with the underlying controls. Their Quality Management System (QMS) may include multiple policies, standards, procedures, templates, and instructions.

Documentation 98

Documentation 98

European Pharmaceutical Review

JULY 4, 2023

However, critical disciplines within the field responsible for ensuring safe and effective drug products, including quality assurance and compliance, remain mysterious or invisible to many. Complex manufacturing processes and development of appropriately qualified or validated test methods present unique challenges which teams must overcome.

Communication 81

Communication Dosage Chemotherapy Documentation 81

European Pharmaceutical Review

JULY 12, 2022

In a paper published in the World Journal of Pharmaceutical Research , researchers sought to understand whether disinfectant validation procedures and sanitisation practices are capable of providing and maintaining a sterile cleanroom environment. Microbial resistance is one of the factors responsible for such failings. luteus and S.

Pharmaceutical Companies 97

Pharmaceutical Companies Pharmaceutical Companies 97

European Pharmaceutical Review

SEPTEMBER 26, 2023

The concept of good pharmacovigilance practice (GVP) has been implemented in multiple regions across the globe to ensure these migrations are validated and data integrity is maintained. If the pharma company requires a phased migration approach to accommodate a regulatory compliance timeline, this method will provide benefits.

Documentation 94

Documentation Data Entry Pharmaceutical Companies Pharmaceutical Companies 94

European Pharmaceutical Review

MARCH 19, 2024

As such “establishing regulatory acceptance and compliance for continuous processes can be a significant challenge”. Additionally, InsightAce Analytic highlighted that as continuous bioprocessing necessitates “standardised equipment, processes, and regulatory guidelines”, this can also be a barrier to adoption.

Documentation 69

Documentation 69

DiversifyRx

OCTOBER 26, 2023

When your pharmacy relies on a Pharmacy Benefit Manager (PBM) for 90% or more of its revenues, it’s imperative to ensure 100% PBM billing compliance so you can pass any PBM audit. Compliance with PBM billing regulations is more critical than ever, given the increasing number of audits conducted each year.

Communication 52

Communication Controlled Substances FDA Independent Pharmacies 52

DiversifyRx

AUGUST 25, 2023

Are you 100% sure you are performing all requirements to maintain compliance with the Controlled Substance Act (CSA)? We all agree that maintaining full compliance is a must, AND the details can fall through the proverbial cracks due to the 1,000 other things we are doing to run our independent pharmacies.

Independent Pharmacies 52

Independent Pharmacies Controlled Substances Patient Care 52

pharmaphorum

JULY 28, 2022

That means maintaining regulatory readiness – because having cGMP compliance problems with the FDA can significantly exacerbate the problem. Until the company is found to be in compliance, there will not be a normal distribution of drug products. In addition to her FDA experience, Ms.

FDA 111

FDA Dosage Documentation Compounding 111

PharmaShots

APRIL 26, 2023

When performing research studies, clinical trial compliance plays a vital part in ensuring the safety and effectiveness of the research. One critical aspect of clinical trial compliance is adhering to Clinical Data Interchange Standards Consortium (CDISC) standards. On a global scale, multiple regulatory bodies oversee clinical trials.

FDA 53

FDA 53

European Pharmaceutical Review

AUGUST 12, 2022

reported that exposure to EO resulted in compliance with Ph. In both APIs, subsequent optimisation of sterilisation parameters did positively influence compliance, so the authors recommend developing a customized dose validation in each case. In summary, exposure to EO resulted in compliance with Ph. for all APIs.

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Pharma Tutor

SEPTEMBER 24, 2020

Pharmacists strive to eliminate medication errors and ensure strict patient compliance to achieve desired therapeutic outcomes. While dispensing the prescription Pharmacists enhance efficacy and safety of medication by motivating patients for compliance of dosage regimen. In this plight patient counselling assumes eminent role.

Dosage 56

Dosage 56

European Pharmaceutical Review

JULY 8, 2022

In an article published in the Journal of Validation Technology (JVT), pharmaceutical microbiologist and contamination control expert Tim Sandle identified ten categories of risk presented by aging. How should cleaning validation sampling locations be chosen?

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122

pharmaphorum

AUGUST 4, 2021

This helps with consistency issues and having full end-to-end traceability ensures audit compliance. . Validation. Every clinical MDR should have validation built in every step of the way. Validation and reporting highlight any compliance deviations from regulatory standards, and alert users as to where issues reside.

Communication 98

Communication Documentation 98

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. It establishes a system of policies based on the organization’s activities, including testing, calibration, validation, and verification. Obviously, SOPs must be clear, user-friendly, and unambiguous.

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52

pharmaphorum

JUNE 8, 2022

Conference Chairman: James Drinkwater, Head of Aseptic Processing Special Interest Group PHSS and Head of GMP Compliance, F Ziel GMBH. Validation Managers. Heads of GMP Compliance. Heads of Quality Compliance. Sponsored by: Dec Group, Rapid Micro Biosystems and STERIS. Who Should Attend? Senior Microbiologists.

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ISPE

MARCH 16, 2023

Both approaches have significant implications for Annex 1 compliance and the role of Contract Manufacturing Organizations (CMOs) in production facilitating these trends. Some of these challenges include for example regulatory compliance, quality control and effective communication between the original manufacturer and the CMO.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Documentation Dosage 98

European Pharmaceutical Review

NOVEMBER 16, 2022

Across all of this is the criticality of compliance with Good Manufacturing and Good Distribution Practice (GMP/GDP) and of a fit-for-purpose quality system. Dr Eduard Cayón is an experienced pharmaceutical industry consultant at bespoke technology and manufacturing supply chain compliance consultancy TDV. About the author.

Documentation 111

Documentation Vaccines 111

The FDA Law Blog

FEBRUARY 7, 2023

It is common to refer to FDA regulations as either pre-market, meaning they are applied before the device may be marketed, or post-market, meaning that compliance is generally required only after the device is brought to market, with some exceptions. Part 803), and reporting corrections and removals (21 C.F.R.

Documentation 98

Documentation FDA Labelling 98

Pharmaceutical Technology

AUGUST 30, 2022

Verista is a Life Sciences business, technology and compliance firm specializing in systems, quality, and validation solutions throughout the product lifecycle. Verista is a leading life sciences business, technology and compliance company that enables clients to improve health and improve lives. The Verdict.

Vaccines 52

Vaccines 52

ISPE

MARCH 29, 2023

Stockton 29 March 2023 We are The Culture Club, a self-formed cross-CoP group of individuals who came together to discuss challenges encountered as we transition quality and validation into the digital world and identify ways to influence cultural changes needed within our industry to better enable innovation. I lead Validation 4.0,

Documentation 96

Documentation 96

pharmaphorum

JANUARY 4, 2022

PRISYM ID provides regulated content and label management solutions designed specifically for life science companies and medical device manufacturers, improving patient safety and health outcomes whilst ensuring regulatory compliance. The post PRISYM ID Achieves Zebra Technologies Validation appeared first on.

Labelling 52

Labelling Packaging 52

ISPE

JANUARY 11, 2023

Cleaning is an important component of a manufacturing process, and the process life-cycle approach should be followed for cleaning validation. Validation of Cleaning Processes (7/93): Guide to Inspections Validation of Cleaning Processes.” 1 US Food and Drug Administration. Chapter 9: Federal Food, Drug, and Cosmetics Act.

Method Validation 52

Method Validation Documentation Packaging Compounding 52

European Pharmaceutical Review

SEPTEMBER 20, 2022

To improve treatment and patient compliance, combination therapies have been developed and approved for use. The methods were validated under International Conference on Harmonisation (ICH) Q2R1 Guidelines with regard to linearity, selectivity, the limit of detection (LOD), limit of quantification (LOQ), and precision and accuracy.

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Impact Pharmaceutical Services

SEPTEMBER 20, 2023

based virtual biopharmaceutical company, who develops drug candidates for neurological diseases, to oversee the Quality and Compliance aspects for the Drug Substances and Drug Products in various phases of Product Development. Challenge Syner-G was contracted by a U.S. The development batches were outsourced from multiple vendors in India.

Documentation 40

Documentation Communication 40

European Pharmaceutical Review

JULY 7, 2022

In an article published in the Journal of GXP Compliance , Moldenhauer explained what can be learned from the observations for a vaccine production facility published in a redacted FDA 483 Report as an example.

Documentation 96

Documentation Vaccines FDA 96

ISPE

SEPTEMBER 15, 2022

Regarding "appropriate technologies“ Annex 1 states: "facility, equipment and process should be appropriately designed, qualified and/or validated and where applicable, subjected to ongoing verification according to the relevant sections of the GMP guide. The use of appropriate technologies (e.g. During the 2022 ISPE Pharma 4.0™

Documentation 97

Documentation FDA 97

ISPE

SEPTEMBER 8, 2023

We describe the principles that facilitate voluntary compliance by the industry. Brooke Higgins Senior Policy Advisor for the Global Compliance Branch 3 FDA/CDER Our guidance does say that integrity testing can be performed prior to processing and that it should be routinely performed post use.

FDA 52

FDA Vaccines Documentation 52

pharmaphorum

DECEMBER 14, 2021

Check to see if all the validation rules are met. You can use the validation tools to see if there’s anything wrong with your datasets before generating your Define-XML. What about validation? ryze validation tools let you check your datasets against rules for standards. So you don’t have to worry about non-compliance.

FDA 52

FDA 52

Impact Pharmaceutical Services

SEPTEMBER 15, 2023

Adhering to CLD best practices is time-consuming, labor-intensive, and costly, but streamlining strategies for accelerating timelines include screening technologies and purpose-fit cell lines to balance speed, quality, and compliance while optimizing cell culture conditions.

Documentation 59

Documentation Process Improvement Compounding 59