GMPSOP

JUNE 28, 2024

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. This article will explore more elements of unplanned deviations than planned deviations. CGMP Deviation: 39 warnings ii.

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GMPSOP

OCTOBER 28, 2023

Packaging material specifications In the pharmaceutical industry, the requirements for pre-printed packaging materials must be well-defined and documented to ensure that you get the items you specified or ordered and that there are no mix-ups. A standard name and a unique item code define packaging materials.

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GMPSOP

OCTOBER 26, 2022

In general, you must formally validate all process steps, production equipment, cleaning methods, testing methods, computer systems and environment, facilities and utilities which are directly used for the manufacture of sterile and non-sterile products. If you have major packaging equipment and processes facilities those should be validated.

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European Pharmaceutical Review

DECEMBER 21, 2022

2 However, most of these efforts relating to catalysis, 3 process waste metrics, 4 lifecycle assessments, 5 pharmaceuticals in the environment 6 and the phase out of substances of concern 7 mainly mitigate the consequences of pharmaceutical manufacturing. Defossilization of pharmaceutical manufacturing.

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GMPSOP

MAY 31, 2024

If you are in the pharmaceutical business, regulatory authorities mandate that you develop, implement, and periodically review a validation master plan for qualifying your systems, processes, cleaning method, testing methodologies, equipment, facilities, etc. The process validation of formulated products (e.g.,

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GMPSOP

MARCH 17, 2023

Table of Contents If you are looking for literary help to write an actionable procedure on corrective and preventive action for your workplace or school, this article will be a good place to start. Further to corrective action, the defective packaging (carton) lot was destroyed which was initially quarantined. Consider this scenario.

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GMPSOP

JULY 14, 2023

In this article, we will discuss important aspects of equipment cleaning that are required during pharmaceutical manufacturing. Equipment cleaning validation protocol was not discussed intensely in this article which was covered elsewhere in this blog.

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GMPSOP

JULY 31, 2023

In this article, we will explore what operational qualification entails, its importance, and FDA requirements. Pharmaceutical manufacturing operations typically maintain equipment varying from simple balances and scales to complex automated process control and monitoring systems. When is equipment qualification necessary?

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