Tag: EMA guidelines

Difficulty in validating cleaning procedures for highly potent APIs.

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Difficulty in validating cleaning procedures for highly potent APIs. Difficulty in Validating Cleaning Procedures for Highly Potent APIs Introduction: In the pharmaceutical industry, maintaining cleanliness is not just a recommendation but a critical requirement, especially when dealing with highly potent active pharmaceutical ingredients (HPAPIs). The validation of cleaning procedures is an essential element in ensuring…

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Capsules (Hard & Soft Gelatin), Solid Oral Dosage Forms

Poor reproducibility in recovery rates for rinse sampling validation.

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Poor reproducibility in recovery rates for rinse sampling validation. Poor reproducibility in recovery rates for rinse sampling validation. Introduction: In the pharmaceutical industry, maintaining rigorous standards for cleanliness and contamination control is paramount. Rinse sampling validation is a critical component of this process, ensuring that manufacturing equipment is adequately cleaned between batches. However, achieving consistent…

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Capsules (Hard & Soft Gelatin), Solid Oral Dosage Forms

Inadequate methods for validating chilled water systems in capsule production facilities.

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Inadequate methods for validating chilled water systems in capsule production facilities. Inadequate methods for validating chilled water systems in capsule production facilities. Introduction: In the pharmaceutical industry, maintaining precise environmental conditions is crucial, particularly in capsule production facilities where the quality of chilled water systems can directly impact product integrity. Chilled water systems play a…

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Capsules (Hard & Soft Gelatin), Solid Oral Dosage Forms

Validating Cleaning Procedures for High-Shear Mixers in Multi-API Tablet Production

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Validating Cleaning Procedures for High-Shear Mixers in Multi-API Tablet Production Validating Cleaning Procedures for High-Shear Mixers in Multi-API Tablet Production Introduction: In the pharmaceutical industry, ensuring the cleanliness of manufacturing equipment is paramount to maintaining the safety and efficacy of drug products. High-shear mixers are integral in the production of tablets, especially those containing multiple…

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Solid Dosage form, Tablets