Tag: compliance

Problems with ensuring consistent lubrication of capsule filling machines.

April 25, 2025 Admin

Problems with ensuring consistent lubrication of capsule filling machines. Problems with Ensuring Consistent Lubrication of Capsule Filling Machines Introduction: In the realm of pharmaceutical manufacturing, capsule filling machines play a pivotal role in ensuring the accurate and efficient production of both hard and soft gelatin capsules. These machines require regular maintenance and lubrication to function…

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

Problems with ensuring consistent performance of dehumidification systems.

April 12, 2025 Admin

Problems with ensuring consistent performance of dehumidification systems. Problems with ensuring consistent performance of dehumidification systems. Introduction: In the manufacturing of solid oral dosage forms, particularly capsules, maintaining the right environmental conditions is crucial. Dehumidification systems play a significant role in ensuring that humidity levels are optimal for processes such as mixing, encapsulation, and storage….

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

Problems with ensuring consistent cleaning of drying trays.

April 10, 2025 Admin

Problems with ensuring consistent cleaning of drying trays. Problems with ensuring consistent cleaning of drying trays. Introduction: In the pharmaceutical industry, maintaining cleanliness in production equipment is paramount to ensure product safety and efficacy. Drying trays, utilized extensively in the manufacturing of solid oral dosage forms like capsules, play a crucial role in the drying…

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

Difficulty in ensuring compliance with bioequivalence requirements for capsules.

April 9, 2025 Admin

Difficulty in ensuring compliance with bioequivalence requirements for capsules. Difficulty in ensuring compliance with bioequivalence requirements for capsules. Introduction: In the pharmaceutical industry, ensuring that generic formulations are bioequivalent to their branded counterparts is crucial. Bioequivalence ensures that a generic drug releases its active ingredient into the bloodstream at the same rate and level as…

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

Poor adhesion of tamper-evident seals to capsule containers.

April 4, 2025 Admin

Poor adhesion of tamper-evident seals to capsule containers. Poor adhesion of tamper-evident seals to capsule containers. Introduction: The pharmaceutical industry places a high premium on ensuring the safety and integrity of its products, and tamper-evident packaging plays a crucial role in achieving this goal. Tamper-evident seals on capsule containers provide a visual indication of product…

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

Difficulty in validating water quality for multi-product capsule facilities.

March 13, 2025 Admin

Difficulty in validating water quality for multi-product capsule facilities. Difficulty in Validating Water Quality for Multi-Product Capsule Facilities Introduction: In the pharmaceutical industry, water quality is a critical component of manufacturing processes, especially in facilities that produce solid oral dosage forms like capsules. Both hard and soft gelatin capsules require water of a specific quality…

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

Addressing Residual Solvent Levels in Coated Tablets During In-Process Control

March 12, 2025 Admin

Addressing Residual Solvent Levels in Coated Tablets During In-Process Control Addressing Residual Solvent Levels in Coated Tablets During In-Process Control Introduction: The pharmaceutical industry is governed by stringent regulations to ensure the safety, efficacy, and quality of products. One critical aspect of manufacturing coated tablets is managing residual solvent levels during in-process control. Residual solvents…

Solid Dosage form, Tablets

Problems with ensuring compliance with pharmacovigilance requirements.

March 12, 2025 Admin

Problems with ensuring compliance with pharmacovigilance requirements. Problems with ensuring compliance with pharmacovigilance requirements. Introduction: Pharmacovigilance plays a critical role in the pharmaceutical industry, ensuring the safety and efficacy of drugs throughout their lifecycle. Compliance with pharmacovigilance requirements is essential for maintaining drug safety, protecting patient health, and fulfilling regulatory obligations. However, achieving and maintaining…

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

Inadequate systems for monitoring cleaning agent residues in rinse water.

March 11, 2025 Admin

Inadequate systems for monitoring cleaning agent residues in rinse water. Inadequate Systems for Monitoring Cleaning Agent Residues in Rinse Water Introduction: Ensuring the cleanliness of pharmaceutical manufacturing equipment is critical to maintaining product safety and efficacy. In the production of solid oral dosage forms, such as capsules, the presence of cleaning agent residues in rinse…

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

Validating Rinse Sampling Protocols for Cleaning Validation in Multi-Product Facilities

March 5, 2025 Admin

Validating Rinse Sampling Protocols for Cleaning Validation in Multi-Product Facilities Validating Rinse Sampling Protocols for Cleaning Validation in Multi-Product Facilities Introduction: In the dynamic field of pharmaceutical manufacturing, maintaining stringent hygiene and safety standards is paramount. Multi-product facilities, which handle the production of various drugs using shared equipment, face unique challenges in preventing cross-contamination. A…

Solid Dosage form, Tablets

Addressing Non-Uniform Temperature Mapping in Fluid Bed Dryers During Validation

March 1, 2025 Admin

Addressing Non-Uniform Temperature Mapping in Fluid Bed Dryers During Validation Addressing Non-Uniform Temperature Mapping in Fluid Bed Dryers During Validation Introduction: Fluid bed dryers are critical components in the pharmaceutical manufacturing process, particularly in the production of solid dosage forms such as tablets. The uniformity of temperature within these dryers is crucial to ensure product…

Solid Dosage form, Tablets