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

GMPSOP

MAY 31, 2024

A validation master plan (VMP) is a strategic document that identifies the elements to validate, the approach to each element, organizational responsibilities, and a strategy for maintaining validation documentation. – General guidance for validation document format. Additional documents included each month.

Documentation

GMPSOP

FEBRUARY 25, 2023

Table of Contents Importance of sampling in pharmaceutical industry Pharmaceutical sampling procedures are carried out during and at each major processing step during the manufacturing to ensure the highest quality is attained. Pharmaceutical sampling procedures ensure all of the above. as their visual aids.

Labelling

GMPSOP

AUGUST 23, 2022

Table of Contents Quality risk management principles are already effectively utilized in many areas of pharmaceuticals manufacturing business. Additional documents included each month. Is this system used in the creation or verification of product labelling (inserts, outserts, cartons or packaging)? Subscribe Step 1.

Documentation

GMPSOP

MAY 26, 2023

The keywords in any change control management process are compliance with regulatory requirements, impact assessment, change verification, and maintain documentation. Why is change control management important in pharmaceuticals? Change control management is a critical and frequently used concept in pharmaceutical industry.

Documentation

GMPSOP

MAY 26, 2023

The keywords in any change control management process are compliance with regulatory requirements, impact assessment, change verification, and maintaining documentation. Why is change control management important in pharmaceuticals? Change control management is a critical and frequently used concept in pharmaceutical industry.

Documentation

pharmaphorum

OCTOBER 27, 2022

The rationale for engaging with certain influencers and digital opinion leaders should be considered and documented. The post New IFPMA and EFPIA guidance on use of social media by the pharmaceutical industry appeared first on. Therefore, companies are encouraged to establish a methodology for calculating fair market value rates.

Communication

GMPSOP

OCTOBER 28, 2023

Typical flow of samples in a quality control laboratory The quality control laboratory receives samples that are collected randomly at the beginning, middle, and end of manufacturing processes. – Document control records management and archiving systems. Additional documents included each month. Checkout sample preview s.

Documentation

GMPSOP

JUNE 28, 2024

Additional documents included each month. Adulterated Pharmaceuticals: 396 warnings iii. Packaging/labeling/Misbranding: 41 warnings vi. Similarly, the packaging, labeling, and misbranding-related warning letters were the top reasons in 2019. Additional documents included each month. Checkout sample preview s.

Documentation

Putting Patients First Blog

APRIL 7, 2025

12 To this end, the NHC encourages the FDA to establish clear expectations for how sponsors validate and document AI-driven findings that are submitted as part of the regulatory dossier. Finally, to support transparency, reproducibility, and traceability, the FDA should require thorough documentation of AI model validation and verification.

Documentation

GMPSOP

MARCH 8, 2024

– Please make sure that proper documentation is maintained and corrective action is undertaken. The FDA subsequently published several guidance documents regarding this matter. Additional documents included each month. Each tablet has the label claim of 100mg (w/w). Additional documents included each month.

Documentation

Quality Matters

AUGUST 3, 2023

While focuses on evaluating and establishing supplier reliability for pharmaceutical manufacturing companies and compounding pharmacies, its high-level elements of supplier qualification can also be applied to suppliers of foods and dietary supplement ingredients.

Packaging

GMPSOP

MARCH 17, 2023

Additional documents included each month. Subscribe Corrective action vs preventive action examples In pharmaceuticals, corrective and preventive action (CAPA), is conducted at the implementation stage of most quality concern investigations. . Additional documents included each month. All written and updated by GMP experts.

Documentation

GMPSOP

MARCH 20, 2024

Additional documents included each month. Additional documents included each month. SOP for instrument calibration: Instrument calibration is important for pharmaceutical manufacturing standards. Could you document the process in the instrument calibration register and the instrument history file? Subscribe f.

Documentation

GMPSOP

APRIL 3, 2024

A pharmaceutical warehouse is responsible for receiving, storing, and releasing incoming goods (including labeling and packaging) and distributing finished products. Therefore, GMP rules ensure that materials are handled and stored properly and that appropriate documentation is maintained. Checkout sample preview s.

Labelling

GMPSOP

DECEMBER 10, 2023

Packaging and labelling mix-ups can potentially result in serious health consequences. Accurate labelling of medicines is critical to patient health. Therefore, manufacturers pay particular attention to getting the right medication and strength into the right container with the correct labels and instructions for use.

Packaging

GMPSOP

JULY 14, 2023

In this article, we will discuss important aspects of equipment cleaning that are required during pharmaceutical manufacturing. Additional documents included each month. Additional documents included each month. Additional documents included each month. All written and updated by GMP experts.

Documentation

GMPSOP

JULY 31, 2023

The FDA sets stringent requirements for operational qualification for critical equipment and systems to ensure the safety and efficacy of pharmaceutical products. These requirements mandate that pharmaceutical companies thoroughly document OQ protocols, testing methods, acceptance criteria, and results.

Documentation

BioPharma Dive

JUNE 5, 2025

Other tasks performed by Elsa included “summarizing adverse events to support safety profile assessments, conducting expedited label comparisons and generating code to facilitate the development of databases for nonclinical applications.” “One scientific reviewer told me what took him two to three days now takes six minutes.”

Drug Pricing

FDA Law Blog: Biosimilars

MAY 13, 2025

Section 5 of the May 12 EO states that within 30 days, HHS will communicate MFN price targets to pharmaceutical manufacturers to bring prices for patients in line with comparably developed nations. (We note our departure from more light-hearted content and absence of musical references. Please bear with us.) 62,094, 62,097 (Oct.

Online Pharmacies

Express Pharma

JANUARY 27, 2025

Proper storage, labelling, and FEFO rotation of incoming materials were highlighted as essential practices. Vendor qualification was presented as a strategic risk management activity, necessitating risk assessment tools, periodic on-site audits, and well-documented SOPs for selection, qualification, and disqualification.

Pharmaceutical Manufacturing

GMPSOP

MARCH 6, 2025

Rework procedure in pharmaceutical manufacturing Step-by-step guide Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Prev PREVIOUS POST A rework procedure is a structured way of correcting quality defects identified in a batch or number of batches of pharmaceutical products.

Pharmaceutical Manufacturing