GMP rules to keep pharmaceutical warehouse in perfect condition Pharmaceuticals quality assurance & validation procedures GMPSOP %title% PrevPREVIOUS POST Pharmaceutical warehouses play a pivotal role in the manufacturing of quality products. The quality of a pharmaceutical product is defined by its purity, efficacy, correctly identifiable characteristics, and safety of use. Customers and patients have an ethical (and legal) right to expect pharmaceutical products to be of the highest quality.  Good warehousing practices ensure just that. Warehouse activities help ensure products re ..read more

Line clearance procedure and reconciliation in GMP Pharmaceuticals quality assurance & validation procedures GMPSOP %title% PrevPREVIOUS POST What is line clearance? Line clearance is a set of activities or checks performed just before an operation can commence. Line clearance ensures the processing line is free of any irrelevant products, components, and documentation that could be left accidentally from an earlier batch.  Line clearance is the first step in a process, and it is to be done before a line opening. Line opening ensures correct products, components, and documentation ..read more

Instrument calibration procedure for pharmaceutical industry Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Last Updated on March 20, 2024 PrevPREVIOUS POST Have you ever wondered if the scales at the grocery checkout show the right amount? Or how are the cameras used on the highways to catch overspeed drivers doing their job correctly? The answer is instrument calibration. Any measuring instrument that counts speed or weight must be calibrated at regular intervals to prove the instrument produces results accurately within its normal range or tolerance. Without ..read more

04 Steps to Investigate Out of Specification (OOS) Result Pharmaceuticals quality assurance & validation procedures GMPSOP %title% PrevPREVIOUS POST What is out of specification (OOS) result? An Out of specification (OOS) result is simply the result that lies outside the specifications to which it is required to conform. When you conduct a quality control test on a finished product or raw material and your test result falls outside of approved, registered, or official specifications, you should assign it an Out of Specification result and commence a rigorous investigation. A confirmed ou ..read more

Good housekeeping practices in GMP Pharmaceuticals quality assurance & validation procedures GMPSOP %title% PrevPREVIOUS POST Good housekeeping practices include establishing cleaning procedures and schedules to ensure washrooms and toilet facilities are properly maintained. Also, please set up procedures to ensure the safe and sanitary disposal of trash and other refuse within and from the Buildings and immediate premises. Department Heads and Supervisors are responsible for indoctrinating and training employees in good housekeeping habits. This article is to help all personnel maintain ..read more

Overview of GLP requirements on everyday laboratory operations Pharmaceuticals quality assurance & validation procedures GMPSOP Overview of GLP requirements on everyday laboratory operations Last Updated on December 24, 2023 PrevPREVIOUS POST Table of Contents Pharmaceutical laboratories conduct sampling, testing, and reporting of medicinal batch results. As such, they perform a vital role in the overall quality assurance of medicinal products and, therefore, must conform to Good Laboratory Practice – GLP requirements. There are several sections of the GLP requirements that specifi ..read more

Steps required to control packaging materials in pharmaceutical Pharmaceuticals quality assurance & validation procedures GMPSOP Steps required to control packaging materials in pharmaceutical Last Updated on December 10, 2023 PrevPREVIOUS POST Table of Contents Pharmaceutical manufacturers implement numerous processes to control packaging materials to avoid costly mix-ups. Particularly the printed packaging materials where product information is presented. Printed packaging materials typically include product names, active ingredients, concentration, batch numbers, expiry dates ..read more

What are the elements of quality control process in pharmaceuticals Pharmaceuticals quality assurance & validation procedures GMPSOP What are the elements of quality control process in pharmaceuticals Last Updated on October 30, 2023 PrevPREVIOUS POST Table of Contents Why do you need to implement a quality control process if you can manufacture products that are free from all possible contaminants? Can you create a system that can eliminate all defects from a product? If possible, this can eliminate the necessity of quality control processes entirely. Until then, we must rely on ..read more

Cleaning validation protocol for pharmaceutical industry Pharmaceuticals quality assurance & validation procedures GMPSOP Cleaning validation protocol for pharmaceutical industry Last Updated on September 28, 2023 by Kazi PrevPREVIOUS POST Table of Contents What is cleaning validation in pharmaceutical industry? Cleaning validation establishes that the cleaning procedure can effectively remove product residue from pharmaceutical equipment to an acceptable limit. Cleaning validation verifies that the cleaning procedure can consistently and significantly reduce the amount of acti ..read more

Warehouse material handling for pharmaceutical industry Pharmaceuticals quality assurance & validation procedures GMPSOP Warehouse material handling for pharmaceutical industry PrevPREVIOUS POST Table of Contents Warehouse plays a significant role in ensuring pharmaceutical product quality. Warehouse material handling activities are at the heart of providing such high-level assurance. Mistakes in these activities can have significant consequences for patient safety, or cause batches to be rejected if discovered early. Therefore, the utmost care must be taken during material hand ..read more