Pharma Pathway

DECEMBER 31, 2022

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

Method Validation

GMPSOP

MAY 31, 2024

This article can help you understand who is responsible for preparing the validation master plan, the stages of the validation life cycle, the risk-based prioritization of validation items, how to prepare a validation schedule, and some practical examples. What is a validation master plan (VMP)?

Documentation

GMPSOP

OCTOBER 26, 2022

Table of Contents What is the concept of validation in pharmaceutical industry? ” Validation is a critical concept in the pharmaceutical industry. .” ” Validation is a critical concept in the pharmaceutical industry. Additional documents included each month. All written and updated by GMP experts.

Documentation

Pharma Pathway

JANUARY 3, 2023

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

Method Validation

GMPSOP

JUNE 9, 2024

Additional documents included each month. employee assay qualification) must be documented in an SOP for each assay the lab performs with pre-determined acceptance criteria. employee assay qualification) must be documented in an SOP for each assay the lab performs with pre-determined acceptance criteria. gown qualification).

Method Validation

Pharma Pathway

JANUARY 30, 2023

Documents To Be Carried: Candidates are requested to carry updated resume, photocopies of educational certificates, and photocopy of Aadhar card and PAN Card copy. Knowledge and handling of HPLC and GC Instruments activities. Knowledge and handling of Wet analysis (LOD, SOR, WC and TLC, Ex.) Knowledge of HPLC and GC Performance Verification.

Method Validation

GMPSOP

OCTOBER 28, 2023

The analyst should ensure that the supervisor is notified as soon as an OOS event occurs, the sample is retained, and a documented investigation is commenced. – Document control records management and archiving systems. Additional documents included each month. All written and updated by GMP experts.

Documentation

GMPSOP

JULY 23, 2023

Installation qualification will provide you with documented evidence that the equipment or system has been designed, developed, supplied, and installed in accordance with design drawings, the supplier’s recommendations, and in-house user requirements. Additional documents included each month. Checkout sample preview s.

Documentation

GMPSOP

DECEMBER 24, 2023

Additional documents included each month. The points below outline some areas in the codes where G(C)LP regulations are embedded in the GMP regulations and guidance documents. Additional documents included each month. All sampling procedures and plans must be documented. All written and updated by GMP experts.

Documentation

GMPSOP

NOVEMBER 19, 2023

Additional documents included each month. If significant trends are identified, they should be documented, and changes should be made to avoid out-of-specification results. The number of batches manufactured, released and rejected should be documented. Additional documents included each month. Checkout sample preview s.

Documentation

GMPSOP

JUNE 16, 2023

According to USP <1224> , method transfer is defined as the documented process that qualifies a laboratory (RL) to use an analytical method originating from another laboratory (TL), regardless of whether it’s internal or external. Additional documents included each month. Checkout sample preview s.

Documentation

GMPSOP

MARCH 4, 2023

Additional documents included each month. Quality management system is primarily involved in ensuring good manufacturing practice (cGMP), good laboratory practice (GLP), good documentation practice (GDP), good automated manufacturing practice (GAMP) etc. What is the probability my cleaning methods weren’t validated?

Documentation

GMPSOP

SEPTEMBER 27, 2023

A pharmaceutical manufacturing plant compliant with Good Manufacturing Practices must have a cleaning validation program in place to establish documented evidence that the cleaning processes will consistently meet expectations by removing the traces of residues from the earlier products. Additional documents included each month.

Method Validation

GMPSOP

NOVEMBER 15, 2024

Additional documents included each month. 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