Pharma Pathway

JANUARY 26, 2023

Sampling of FG/RM/PM Analytical Method Validation & Calibration Date of Interview: 29th Jan’ 2023 Interview Time: 09:00 AM to 16:00 PM Venue Details: Rang Lords Inn Nr.

Method Validation 83

Method Validation 83

Pharma Pathway

JANUARY 26, 2023

Sampling of FG/RM/PM Analytical Method Validation & Calibration Date of Interview: 29th Jan’ 2023 Interview Time: 09:00 AM to 16:00 PM Venue Details: Rang Lords Inn Nr.

Method Validation 75

Method Validation 75

European Pharmaceutical Review

APRIL 2, 2024

Timely implementation of the reference to USP <86> in the water for injection and purified water monographs is desired to encourage and enable the adoption of these methods for environmental monitoring purposes. Want to learn more about endotoxin testing and validation…?

Method Validation 98

Method Validation Medical Schools 98

Pharma Pathway

JANUARY 27, 2023

Experience: 01 to 04 years Department: AR&D- Method Validation API (Males) Qualification: M.Sc/ M. Pharmacy (Analytical Chemistry) Experience: 01 to 03 years in HPLC- Method Validation Department: AR&D- Method Development (Males) Qualification: M.Sc/ M.

Method Validation 52

Method Validation 52

European Pharmaceutical Review

MARCH 6, 2024

Additionally, the new laboratory offers Ariceum the ability to carry out on-site process, method, validation and formulation development as well as preliminary stability analysis of its radiolabeled compounds.

Method Validation 105

Method Validation Clinical Pharmacology Compounding 105

Pharma Pathway

FEBRUARY 28, 2023

Analytical method development and Characterization using HPLC, GC, LCMS, GCMS, NMR, DSC, TGA, Raman Raman Spectroscopy and XRD in drug substance and drug products. Analytical method validations in GMP environment.

Method Validation 77

Method Validation 77

Pharma Pathway

JANUARY 2, 2023

Experience in Analytical Method Development and Characterisation using HPLC, GC, LCMS, GCMS, NMR, DSC, TGA, Raman Spectroscopy and XRD in Drug substance and drug products. Experience in Analytical method validations in GMP environment. Date: 7th Jan’ 2023. Time: 09:30 AM to 02:30 PM.

Method Validation 78

Method Validation 78

Pharma Pathway

DECEMBER 14, 2022

Department: AR&D- (Method Validation). Experience: 01 to 04 years in HPLC- Method Validation. Department: R&D- (Synthesis / Process/ CRO). Qualification: M.Sc. Experience: 01 to 04 years. Qualification: M.Sc/ M. Pharmacy (Analytical Chemistry). Department: Regulatory Affairs (API). Qualification: M.Sc/ M.

Method Validation 52

Method Validation 52

Pharma Pathway

SEPTEMBER 14, 2022

Skill Set: Method Validation/ Verification analysis hands HPLC/ GC/ LCMS/ ICPMS etc., Experience : 02 to 08 years with relevant Experience. Walk-In for Quality Control -Officer/ Executive at Eye Drop Plant. Role & Responsibilities: . Required for Sterile Area: . and preference will be given to those are handling Empower software.

Method Validation 77

Method Validation Documentation 77

European Pharmaceutical Review

NOVEMBER 21, 2024

With over 22 years of experience, she has worked as a QC microbiologist in cell therapy and non-sterile pharmaceutical manufacturing, specialising in environmental monitoring and method validation. The post Understanding endotoxin cartridge testing: frequently asked questions appeared first on European Pharmaceutical Review.

Method Validation 52

Method Validation Pharmaceutical Manufacturing 52

Pharma Pathway

DECEMBER 31, 2022

Involved in Analytical method Validation. Role & Responsibilities: Responsible for IPQC, DS, DP and Stability sample testing on routine basis. Preparation of STP/ SOP/ DRS for QC Documentation. Instruments and Equipment handling for routine use as well as calibration and qualification.

Method Validation 52

Method Validation Documentation 52

European Pharmaceutical Review

JULY 3, 2025

The implications of this publication are that the bar for the use of alternative methods is lowered for the products that could benefit from them the most, and in turn, benefits the patients who need therapies as quickly as possible.

Pharmaceutical Manufacturing 69

Pharmaceutical Manufacturing Method Validation 69

European Pharmaceutical Review

JANUARY 25, 2024

Leachable studies leachables can stem from different sources and be formulation dependent” “Because leachables can stem from different sources and be formulation dependent” sufficient data should be provided to identify and characterise the potential risks associated with the leachables from the CCS.

Documentation 98

Documentation Method Validation Packaging Labelling 98

Pharma Pathway

JANUARY 3, 2023

Skill Set: Stability & Method validation / verification analysis hands on experience HPLC/ GC/ LCMS/ ICPMS etc., Skill Set: Microbiology Analytical Activities, Reviewer, QMS documentation and Environmental Monitoring in Sterile manufacturing facility. Microbiology / BioTech. 5-12 years of relevant experience.

Method Validation 52

Method Validation Documentation 52

Pharma Pathway

JANUARY 30, 2023

Knowledge and handling of HPLC and GC Instruments activities. Knowledge and handling of Wet analysis (LOD, SOR, WC and TLC, Ex.) activities Troubleshooting for all handling instruments.

Method Validation 52

Method Validation Documentation 52

Pharma Pathway

JANUARY 2, 2023

Experience in Analytical Method Development and Characterisation using HPLC, GC, LCMS, GCMS, NMR, DSC, TGA, Raman Spectroscopy and XRD in Drug substance and drug products. Experience in Analytical method validations in GMP environment. Date: 7th Jan’ 2023. Time: 09:30 AM to 02:30 PM.

Method Validation 52

Method Validation 52

pharmaphorum

DECEMBER 16, 2021

Gain insight the current state of Endotoxin testing, including alternative test methods and strategic approaches to method validation. Key Reasons to Attend: Discover case studies in establishing holistic Contamination Control Strategies and Real-Time Viable Air Particle Counting with leaders in the pharmaceutical industry.

Method Validation 52

Method Validation 52

GMPSOP

JUNE 9, 2024

Test method validation in quality control Analytical Method Validation for Quality Control Test method validation generally means the same as analytical method validation, where the terms are interchangeable. Maintenance programs must be documented for laboratory equipment.

Method Validation 52

Method Validation Documentation Health and Personal Care Stores Labelling 52

Pharmaceutical Technology

AUGUST 24, 2022

To ensure the quality of FCM assay performance in preclinical and clinical applications, several scientific organizations developed recommendations for FCM instrumentation and method validation. The FDA and/or other regulatory agencies typically request validation reports to evaluate the assay performance for the intended purpose.2,3.

Method Validation 52

Method Validation Immunity Immunization Drug Development 52

GMPSOP

MAY 31, 2024

You can read our article “ Equipment Cleaning in Pharmaceutical ” to explore cleaning validation further. If you need help with complete guidance, please refer to the cleaning validation master plan. Method validation master plan? Create a master plan listing all products, specifications, and test methods.

Documentation 59

Documentation Method Validation Pharmaceutical Companies Pharmaceutical Companies 59

GMPSOP

OCTOBER 26, 2022

What is method validation in pharmaceutical industry? Analytical method validation involves demonstrating that the analytical methods used to test the quality of your product are accurate, reliable and reproducible which is critical for ensuring the quality and safety of your products.

Documentation 52

Documentation Method Validation Packaging Pharmaceutical Companies 52

Express Pharma

MAY 22, 2023

But, the excitement to leverage the growth potential in nutraceuticals has been countered by challenges like the lack of an effective approach/guideline for clinical proofs, clinical trials, factory audit standards, bioactive standardisation, method validations, etc.

Dosage 105

Dosage Method Validation Labelling Immunity 105

FDA Law Blog: Biosimilars

FEBRUARY 13, 2025

FDA recommends that the following information be made public regarding the PCCP as appropriate: planned modifications, testing methods, validation activities and performance requirements to meet before implementation, and means by which users will be informed of the implementation of the modification.

Documentation 71

Documentation Labelling Method Validation Communication 71

GMPSOP

OCTOBER 28, 2023

Validated test method A test method comprehensively describes all procedures used in sample analysis. Analytical test method validation guarantees that your test method is robust enough to provide evidence if your product meets the predetermined product specification or conforms to the failure of a product.

Documentation 52

Documentation Method Validation Packaging Data Entry 52

GMPSOP

APRIL 3, 2023

Adapted and non-standard methods must be validated. Protocols are only used for specific projects such as method validation testing or equipment qualification. – Methods for data analysis and interpretation, including the statistical techniques to be used.

Documentation 52

Documentation Method Validation Compounding Data Entry 52

GMPSOP

DECEMBER 24, 2023

Laboratory documentation and records that should be available include: – Test methods and test reports – Laboratory notebooks/sheets, instrument records, and calculations – Conditions of tests and instrument settings. – Test method validation protocols, data and reports – Other records and data i.

Documentation 40

Documentation Method Validation Packaging Data Entry 40

epicur

JANUARY 18, 2024

While both BUDs and expiration dates serve a similar purpose of decreasing patient risks associated with any changes a medication may undergo during storage, expiration dates have key advantages : Expiration dates have a high degree of accuracy—they are determined using stability testing methods validated by cGMP regulations enforced by the FDA.

Compounding 52

Compounding Compounding Pharmacies Dosage Method Validation 52

GMPSOP

NOVEMBER 19, 2023

All validation/qualification studies commenced or completed during the review period must be assessed. The effectiveness of the validation must be determined.

Documentation 52

Documentation Packaging Method Validation Process Improvement 52

GMPSOP

JUNE 16, 2023

In this option, the RL has to assess all the risks and mitigate those risks by repeating the test parameters and matching the results against the original validation data. It’s essential to review the TL’s validation approach in accordance with current ICH Q2 guidelines and ensure that it covers the intended use of the method.

Documentation 52

Documentation Dosage Communication Method Validation 52

GMPSOP

JULY 23, 2023

Validation of testing methods: Validate all testing methods used during the qualification process to ensure the accuracy and reliability of results. Well-documented processes: Maintain detailed records throughout the qualification process. 240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms.

Documentation 52

Documentation Method Validation Packaging Labelling 52

GMPSOP

SEPTEMBER 27, 2023

Cleaning validation, including analytical method validation, should be conducted for the new product. Validate analytical method for cleaning validation After selecting the worst-case product check if an analytical method is validated for that product. Additional documents included each month.

Method Validation 98

Method Validation Documentation Pharmaceutical Manufacturing Dosage 98

GMPSOP

MARCH 4, 2023

If my cleaning methods are not validated would they cause contamination of my products? What is the probability my cleaning methods weren’t validated? Should I implement a more robust cleaning method validation to mitigate such risk? Do I have adequate control in place?

Documentation 52

Documentation Communication Method Validation Packaging 52

GMPSOP

NOVEMBER 15, 2024

With the appropriate detector sensitivity, column, and mobile phase, stability-indicating methods are very useful for determining degradant concentrations. Forced degradation studies – method validation Forced degradation studies validate the analytical method as stability-indicating in nature.

Packaging 59

Packaging Dosage Documentation Labelling 59

GMPSOP

JUNE 15, 2025

– Test method validation and change control – Documentation – Sample handling and storage 2. – Media sterilisation must be validated and monitored for every batch. For instance, calibration of temperature monitoring devices for incubators. – Storage of media must be controlled.

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing Health and Personal Care Stores Documentation Compounding 52

Express Pharma

MAY 23, 2025

Organizations are expected to employ staff with expertise in specialised areas such as microbiology, radioisotope testing, and analytical method validation. The new drug rules place strong emphasis on building human capital in pharmaceutical quality control. This expands their role from operational support to strategic oversight.

Method Validation 69

Method Validation Pharmaceutical Companies Pharmaceutical Companies 69