Tag: Regulatory compliance

Difficulty in ensuring proper documentation for quality-related investigations.

May 2, 2025 Admin

Difficulty in ensuring proper documentation for quality-related investigations. Difficulty in ensuring proper documentation for quality-related investigations Introduction: In the pharmaceutical industry, ensuring comprehensive and meticulous documentation for quality-related investigations is not just a regulatory requirement but a cornerstone for maintaining product efficacy and patient safety. Documentation serves as the evidence of compliance with Good Manufacturing…

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

Preventing Incorrect Barcode Printing on Tablet Packaging Materials

May 2, 2025 Admin

Preventing Incorrect Barcode Printing on Tablet Packaging Materials Preventing Incorrect Barcode Printing on Tablet Packaging Materials Introduction: In the pharmaceutical industry, accurate barcode printing on packaging is crucial for ensuring patient safety, regulatory compliance, and efficient supply chain management. Barcodes facilitate the tracking and tracing of pharmaceutical products, aiding in the prevention of counterfeit drugs…

Solid Dosage form, Tablets

Challenges in preventing capsule discoloration during long-term storage.

May 2, 2025 Admin

Challenges in preventing capsule discoloration during long-term storage. Challenges in Preventing Capsule Discoloration During Long-Term Storage Introduction: In the pharmaceutical industry, maintaining the integrity and appearance of solid oral dosage forms, such as capsules, throughout their shelf life is crucial for ensuring product efficacy and patient compliance. Capsules, whether hard or soft gelatin, are susceptible…

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

Managing API Degradation in Film-Coated Tablets Stored at High Temperatures

May 1, 2025 Admin

Managing API Degradation in Film-Coated Tablets Stored at High Temperatures Managing API Degradation in Film-Coated Tablets Stored at High Temperatures Introduction: In the pharmaceutical industry, the stability of Active Pharmaceutical Ingredients (APIs) is crucial for ensuring the efficacy and safety of medications. Film-coated tablets are a popular dosage form, offering benefits such as ease of…

Solid Dosage form, Tablets

Problems with maintaining consistent capsule transparency over time.

May 1, 2025 Admin

Problems with maintaining consistent capsule transparency over time. Problems with maintaining consistent capsule transparency over time. Introduction: In the pharmaceutical industry, the appearance of a capsule is not merely an aesthetic concern but a critical quality attribute. Transparency in capsules, especially those made from gelatin, is vital for consumer trust and product acceptance. Over time,…

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

Addressing Residual Binder Accumulation in Granulation Equipment During Cleaning Validation

May 1, 2025 Admin

Addressing Residual Binder Accumulation in Granulation Equipment During Cleaning Validation Addressing Residual Binder Accumulation in Granulation Equipment During Cleaning Validation Introduction: In pharmaceutical manufacturing, especially in the production of solid dosage forms like tablets, the granulation process is a critical step. However, residual binder accumulation in granulation equipment poses a significant challenge during cleaning validation….

Solid Dosage form, Tablets

Ensuring Robustness in Weight Variation Control During Compression Validation

May 1, 2025 Admin

Ensuring Robustness in Weight Variation Control During Compression Validation Ensuring Robustness in Weight Variation Control During Compression Validation Introduction: In the pharmaceutical industry, ensuring the uniformity and consistency of tablet production is crucial. Weight variation in tablets can lead to significant quality issues, impacting both efficacy and safety. This makes weight variation control a critical…

Solid Dosage form, Tablets

Inadequate inspection systems for detecting visual defects in capsules.

May 1, 2025 Admin

Inadequate inspection systems for detecting visual defects in capsules. Inadequate Inspection Systems for Detecting Visual Defects in Capsules Introduction: In the pharmaceutical industry, ensuring the quality and safety of solid oral dosage forms, such as capsules, is paramount. Capsules, whether hard or soft gelatin, are popular for their convenience and effectiveness in delivering medications. However,…

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

Difficulty in establishing validated cleaning procedures for semi-solid formulations.

April 30, 2025 Admin

Difficulty in establishing validated cleaning procedures for semi-solid formulations. Difficulty in Establishing Validated Cleaning Procedures for Semi-Solid Formulations Introduction: In the pharmaceutical industry, maintaining cleanliness and avoiding cross-contamination are paramount, particularly when dealing with semi-solid formulations. These formulations, which include creams, ointments, gels, and pastes, present unique challenges in terms of cleaning validation due to…

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

Troubleshooting Surface Roughness in Sugar-Coated Tablets During Storage

April 30, 2025 Admin

Troubleshooting Surface Roughness in Sugar-Coated Tablets During Storage Troubleshooting Surface Roughness in Sugar-Coated Tablets During Storage Introduction: Sugar-coated tablets are a prevalent form of oral pharmaceutical dosage due to their aesthetic appeal, taste masking abilities, and protective properties. However, during storage, these tablets can sometimes develop surface roughness, which can compromise their appearance, consumer acceptance,…

Solid Dosage form, Tablets

Challenges in predicting the impact of high humidity on capsule disintegration times.

April 30, 2025 Admin

Challenges in predicting the impact of high humidity on capsule disintegration times. Challenges in predicting the impact of high humidity on capsule disintegration times. Introduction: In the realm of pharmaceutical manufacturing, ensuring the efficacy and stability of solid oral dosage forms such as capsules is paramount. Capsules, both hard and soft gelatin, are a prevalent…

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

Problems with detecting capsule defects during in-process visual inspection.

April 29, 2025 Admin

Problems with detecting capsule defects during in-process visual inspection. Problems with Detecting Capsule Defects During In-Process Visual Inspection Introduction: In the pharmaceutical industry, ensuring the quality of solid oral dosage forms, such as capsules, is paramount. Capsules, whether hard or soft gelatin, are among the most common forms of drug delivery due to their ease…

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