Pharma Pathway

FEBRUARY 15, 2023

Department: 21CFR Part 11 Compliance (Formulation & API) Position: Officer to Executive Qualification: M.Pharm/ M.Sc Experience: 03 to 5 years To Check compliance to 21CFR – instruments and equipment, Activation of policy, Periodic Audit trail review. Having Good regulatory audit Exposure.

Documentation 63

Documentation 63

Express Pharma

AUGUST 6, 2023

The inspection established that the facility is in an “Acceptable State of Compliance” with Zero Form 483 inspectional observations from the Agency. The result of these inspections demonstrates our commitment to regulatory excellence at our global manufacturing sites and our relentless focus on world-class quality and compliance.

Packaging 95

Packaging 95

European Pharmaceutical Review

NOVEMBER 15, 2022

Since their outset the GAMP guides have promoted using a balanced risk-based pragmatism to achieve compliance and the July 2022 release of GAMP 5 second edition strongly encourages the use of critical thinking to support that. The validation of commercially available software applications has largely followed the GAMP V-model.

Documentation 84

Documentation Pharmaceutical Companies Pharmaceutical Companies 84

PharmaTech

SEPTEMBER 12, 2022

Validation is an important process to ensure cleanrooms meet specific standards. A comprehensive cleanroom monitoring strategy combines data acquisition, analysis, and reporting to support compliance efforts and protect valuable scientific work. Read how continuous monitoring supports validation and compliance in our white paper.

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European Pharmaceutical Review

MARCH 13, 2024

“Non-contemporaneous documentation on laboratory worksheet records raises concerns about the validity and integrity of your firm’s laboratory testing records,” FDA added. The letter listed remediation activities, pointing to FDA guidance on Data Integrity and Compliance with Drug cGMP.

Documentation 89

Documentation Pharmaceutical Manufacturing 89

European Pharmaceutical Review

MARCH 8, 2024

defined GAMP as ‘good automated manufacturing practices’, with GAMP 5 being “a widely used framework for validating automated systems that establishes quality assurance practices. Therefore, GAMP 5 offers a “significant reduction in the risk of errors and ensuring compliance with regulatory standards”, according to the authors.

Drug Development 82

Drug Development 82

European Pharmaceutical Review

MARCH 12, 2024

Ensuring data integrity in the life science industry is crucial for regulatory compliance. There is growing awareness of the importance of implementing robust data governance frameworks and compliance programmes to ensure the integrity of data. How can this be mitigated? Training and education.

Documentation 88

Documentation Data Entry Communication Compounding 88

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.

Documentation 91

Documentation Pharmaceutical Manufacturing Packaging Labelling 91

PharmaTech

OCTOBER 10, 2023

Specialization in ophthalmic manufacturing, demonstrated by investment in equipment, technical project management, quality systems, and regulatory compliance, ensures a safe, effective eyecare drug product.

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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 95

Documentation Pharmaceutical Companies Pharmaceutical Companies 95

Express Pharma

FEBRUARY 13, 2024

The facility has ensured compliance with quality and regulatory requirements of the healthcare industry.

Packaging 74

Packaging Documentation Labelling 74

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?

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Pharma Pathway

JANUARY 30, 2023

Routine monitoring of the equipment, facility and utilities for GMP Compliance. Execution of documentation activities of liaison with QA & QC for GMP Compliance. Participate and Executive Compliance of Validation/ Qualification documents.

Documentation 66

Documentation Vaccines 66

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 123

Documentation 123

Pharma Pathway

SEPTEMBER 15, 2022

Job Profile: Having experience in Analytical Validation/ HPLC/ GC Analysis and Compliances/ Master Preparation of LIMS and Execution of LIMS. Position: Officer to Executive. Experience: 02 -09 years. Qualification: M.Sc- Chemistry/ B.Pharmacy/ M.Pharmacy. Date: 16th Sept’ 2022. Time: 10:00 AM to12:00 PM.

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GMPSOP

DECEMBER 24, 2023

It sets the standards for performing tests and generating data in a reliable, reproducible, and valid way. Compliance with GLP requirements is essential for pharmaceutical product research, development, and testing laboratories. GLP compliance also helps maintain laboratory personnel’s safety and the environment.

Documentation 52

Documentation Method Validation Packaging Data Entry 52

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 87

Method Validation Medical Schools 87

Drug Channels

SEPTEMBER 18, 2023

Showcasing high level discussions on access strategy, patient interactions, case management, compliance practices and more, this two-and-a-half-day event helps navigate complex compliance hurdles to advance and enhance your patient-oriented programs. Offer not valid on workshop only or academic/non-profit registrations.

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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.

Pharmaceutical Manufacturing 122

Pharmaceutical Manufacturing Drug Development 122

FDA Law Blog: Biosimilars

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.

Documentation 105

Documentation 105

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.

Drug Development 80

Drug Development Communication Dosage Chemotherapy 80

Pharmaceutical Business Review

MAY 8, 2023

Nexus Pharmaceuticals stated that the regulatory approval process validates facilities’ compliance with stringent quality and safety standards. The inspection will allow the company to commence commercial operations at the three-storey, 84,000ft² manufacturing facility.

Pharmaceutical Manufacturing 96

Pharmaceutical Manufacturing Packaging Hospitals 96

Express Pharma

MAY 16, 2023

The third Annual Computer Software Assurance 2023 aims to strengthen and empower Computer System Validation (CSV) and provide key insights on the CSA approach. IT Compliance Teams 4. Eminence Business Media recently announced the third Annual Computer Software Assurance 2023, Live and In-stereo. WHO CAN ATTEND 1. IT Quality Teams 2.

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90

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 Manufacturing 96

Pharmaceutical Manufacturing Pharmaceutical Companies Pharmaceutical Companies 96

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 93

Documentation Data Entry Pharmaceutical Companies Pharmaceutical Companies 93

Pharma in Brief

JANUARY 17, 2024

The Federal Court of Appeal ( FCA ) held that it is abuse of process for a generic or biosimilar manufacturer to split its case across multiple notices of allegation ( NOAs ) under the Patented Medicines (Notice of Compliance) Regulations ( Regulations ). In the trial related to invalidity, the 335 Patent was found to be valid.

Biosimilars 52

Biosimilars 52

Pharma in Brief

FEBRUARY 28, 2024

PMS ) sought a Notice of Compliance to market a generic version of INVEGA SUSTENNA ® (the PMS Product ). Janssen commenced an infringement action under section 6 of the Patented Medicines (Notice of Compliance) Regulations. The Federal Court ( FC ) found the claims of the 335 Patent valid. Pharmascience Inc. ( v Janssen Inc.

Dosage 52

Dosage 52

Express Pharma

JUNE 26, 2023

Recognising the significance of ensuring nutraceutical safety, the need for clinical trials to validate potential side effects and toxicity arises. Nutrify Genie emerges as the solution to the demand for ethical nutraceutical label claim generation through real-time toxicological screening, IP validation, and regulatory compliance.

Labelling 117

Labelling Compounding 117

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 68

Documentation 68

GMPSOP

AUGUST 16, 2023

Process Validation Guidelines for Formulated Products Pharmaceuticals quality assurance & validation procedures GMPSOP Process Validation Guidelines for Formulated Products The Process Validation must ensure by testing that a process is capable of repeatedly and reliably produce a formulated product of the required quality.

Dosage 40

Dosage Documentation 40

Pharma Pathway

NOVEMBER 4, 2022

Executive/ Assistant Manager with 6 to 9 years of experience in Internal audits, Statutory compliances, Labor Laws, Online ECR Submission, SOP’s, T & D, Payroll management. Officer/ Executive with 4 to 7 years of experience in Validation, strumental Analysis, Regulatory audit exposur must.

Communication 52

Communication 52

Pharmaceutical Business Review

FEBRUARY 9, 2024

Aizon CEO and co-founder Pep Gubau said: “This investment is pivotal to the future growth of our company as it validates the success of our platform and enables us to better execute on our strategic roadmap. The capital injection will be instrumental for Aizon to expand its reach and capabilities in the pharmaceutical manufacturing sector.

Pharmaceutical Manufacturing 59

Pharmaceutical Manufacturing Customer Service 59

GMPSOP

NOVEMBER 19, 2023

Change management All approved change controls that could impact product quality, validation status and/or regulatory filing for the specific product must be reviewed. All validation/qualification studies commenced or completed during the review period must be assessed. Any trends should be analysed.

Documentation 52

Documentation Packaging Method Validation Process Improvement 52

Express Pharma

APRIL 21, 2023

The Dholka manufacturing facility passed the USFDA audit with nil 483 observations, which signifies compliance and conformance to applicable Current Good Manufacturing Practice (cGMP) regulations enforced by the USFDA. USFDA Inspector Vivin George conducted the facility’s audit from April 3 to 7.

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GMPSOP

AUGUST 14, 2023

Pharmaceuticals quality assurance & validation procedures GMPSOP How to perform periodic review of systems and processes in pharmaceuticals? Your testing methods are so robust to generate any error or cleaning methods are so rigorously validated that you are not worried about cross-contamination. Sounds too good to be true.

Documentation 52

Documentation Pharmaceutical Manufacturing Packaging 52

GMPSOP

JULY 23, 2023

If you remember the (V) shaped model that is commonly used to map the computer system validation life cycle? If you are completely unfamiliar with what is installation qualification then we suggest you read the article Validation in Pharmaceutical Industry first. That will give you a sense of what does installation qualification do?

Documentation 52

Documentation Method Validation Packaging Labelling 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.

Diabetes 102

Diabetes Dosage Pharmaceutical Manufacturing Documentation 102