GMPSOP

NOVEMBER 19, 2023

You should perform product quality review annually to determine if any adjustments to product specifications, manufacturing process or raw material supply are required to improve the product further. The scope of this article applies to all regulated medicinal products manufactured at a GMP site that undergo annual product quality review.

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Documentation Packaging Method Validation Process Improvement 52

European Pharmaceutical Review

MAY 29, 2023

Recently, the European Medicines Agency (EMA) took the lead in pushing for process improvements using technologies already established in other manufacturing sectors. As these products are parenteral and according to the GMP are sterile, the costs associated with their manufacturing are high.

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Process Improvement Packaging Vaccines Drug Development 71

GMPSOP

JULY 14, 2023

Also, laboratory testing for potential contaminants after every use of a piece of equipment is generally not practical, economical, or reliable. What you will need are properly validated equipment cleaning procedures and a well-defined cleaning and verification regime in order to make sure your products are free from unnecessary contaminants.

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Documentation Labelling Pharmaceutical Manufacturing Packaging 52

GMPSOP

AUGUST 28, 2023

Warehouse material handling for pharmaceutical industry Pharmaceuticals quality assurance & validation procedures GMPSOP Warehouse material handling for pharmaceutical industry Prev PREVIOUS POST Table of Contents Warehouse plays a significant role in ensuring pharmaceutical product quality.

Health and Personal Care Stores 52

Health and Personal Care Stores Labelling Packaging Documentation 52

GMPSOP

JULY 23, 2023

You will also know the relationship between design qualification and installation qualification, and best practices for achieving a successful installation qualification. You will also know the relationship between design qualification and installation qualification, and best practices for achieving a successful installation qualification.

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Documentation Method Validation Packaging Labelling 52

GMPSOP

DECEMBER 28, 2022

Environmental monitoring is a documented program which describes the routine particulate and microbiological monitoring of processing and manufacturing areas. The program includes a corrective action plan when action levels are exceeded. What is environmental monitoring in pharmaceutical industry?

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Documentation Vaccines 52

GMPSOP

AUGUST 14, 2023

Pharmaceuticals quality assurance & validation procedures GMPSOP How to perform periodic review of systems and processes in pharmaceuticals? Sounds too good to be true. How to perform periodic review of systems and processes in pharmaceuticals? Packaging lines are fully automated and working without any hiccups.

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Documentation Pharmaceutical Manufacturing Packaging 52

GMPSOP

APRIL 3, 2024

GMP rules to keep pharmaceutical warehouse in perfect condition Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Prev PREVIOUS POST Pharmaceutical warehouses play a pivotal role in the manufacturing of quality products. Good warehousing practices ensure just that.

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Labelling Packaging Documentation Inventory Control 52

GMPSOP

OCTOBER 28, 2023

Companies, therefore, have to rely upon GMP rules and quality management systems to prevent these problems from occurring in the first place. Quality control is the part of quality assurance systems that checks the quality of a batch after it has been manufactured. Can you create a system that can eliminate all defects from a product?

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Documentation Method Validation Packaging Data Entry 52

GMPSOP

AUGUST 23, 2022

Table of Contents Quality risk management principles are already effectively utilized in many areas of pharmaceuticals manufacturing business. Our scope includes systems and processes that support manufacture and distribution of active pharmaceutical ingredients and drug products. How to apply quality risk management in validation?

Documentation 52

Documentation Communication Pharmaceutical Manufacturing Labelling 52

GMPSOP

MARCH 30, 2024

Line clearance procedure and reconciliation in GMP Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Prev PREVIOUS POST What is line clearance? Line opening ensures correct products, components, and documentation are brought into the processing line so the operation can commence without error.

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Labelling Packaging Documentation Pharmaceutical Manufacturing 52

RX Note

JUNE 3, 2023

I believe, a great majority of pharmacists started this career with great passion to help patients. However, not all of us has an equal accessibility to excellent training and support. Despite enormous efforts, the knowledge gap widens. Plus, once graduated, learning is mostly on our own initiatives. What are the powers of a minister?

Health and Personal Care Stores 40

Health and Personal Care Stores Chemotherapy Compounding Dosage 40

GMPSOP

APRIL 19, 2024

Guideline for Excel spreadsheet validation Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Prev PREVIOUS POST Excel spreadsheet validation involves developing and testing spreadsheet applications and confirming that the information generated through the spreadsheet is accurate, complete, intended, and reproducible.

Documentation 52

Documentation Data Entry Communication Pharmaceutical Companies 52

GMPSOP

DECEMBER 10, 2023

One of the ways to ensure that medicinal products are safe and effective is by packing finished products into packaging materials imprinted with correct information. 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 52

Packaging Health and Personal Care Stores Labelling Documentation 52

GMPSOP

JULY 31, 2023

How to perform operational qualification – step by step Pharmaceuticals quality assurance & validation procedures GMPSOP How to perform operational qualification – step by step Table of Contents Operational qualification (OQ) verifies that the functional specifications meet the operating criteria of critical equipment. Let’s begin.

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Documentation Dosage Labelling Data Entry 52

GMPSOP

AUGUST 16, 2023

That is why regulatory agencies inspect this area with proper diligence to make sure plants are operating under stringent GLP (Good Laboratory Practice) and GMP (Good Manufacturing Practice) guidelines. Practices should be established at each GMP site to assure laboratory housekeeping is maintained.

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Documentation Labelling Compounding 40

The Thyroid Pharmacist

JULY 14, 2023

I personally haven’t seen too many reports of these “spontaneous regenerations of thyroid tissue,” outside of postpartum thyroiditis cases; rather, I work with clients who take action to induce remission of their conditions, and in some cases, these clients also show a regeneration of thyroid tissue. However, this isn’t always true!

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Dosage Immunity Immunization Documentation 97

GMPSOP

OCTOBER 16, 2022

Table of Contents Good documentation practice requires a system for control, implementation, maintenance and archival of GMP related documents and records. To implement good documentation practice and systems the site must assure that GMP documents and records are adequate, approved and in compliance with applicable GMP requirements.

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GMPSOP

MARCH 4, 2023

Like many other industries nowadays, quality risk management is a critical concept to practice in pharmaceutical operations. When you will start practicing risk management philosophy, tools and techniques you will find your decision-making process has significantly improved. And that is for all the right reasons.

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Documentation Communication Method Validation Packaging 52

Ramblings of a pharmacist

SEPTEMBER 26, 2023

The point of this law from my perspective is to attempt to prevent counterfeit products from entering the drug supply chain. As an industry, we should absolutely take actions to prevent that kind of fraud. Thanks for reading Ramblings of a pharmacist! Subscribe for free to receive new posts and support my work.

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Communication Pharmaceutical Manufacturing Documentation 105

The Thyroid Pharmacist

SEPTEMBER 12, 2022

I still worry about my looks these days, but I’ve also gained more of an appreciation for how “necessary” certain beauty procedures can be, to keep us looking our best after long nights of very little sleep! In this article, we’ll explore: Common beauty procedures, such as the Brazilian blowout, hair dyeing, breast augmentation, and Botox.

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Health and Personal Care Stores Immunity Immunization Labelling 78

RX Note

FEBRUARY 23, 2023

Alternatively, you can also use the search feature at the top right corner. Ancora imparo: I am still learning. Disclaimer: Rx Note shall not be liable for any loss whatsoever arising from the use of information obtained from the website. The information provided is meant to act as a guide and should not substitute professional clinical judgement.

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HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 75