BioPhorum’s Post

Can containers, closures, and packaging materials be sampled for receipt examination in the warehouse? Yes. Generally, we believe that sampling in a typical drug manufacturing facility warehouse would not represent a risk to the container or closure or affect the integrity of the sample results. But whether the act of collecting a sample in the warehouse violates the CGMP requirement that containers "be opened, sampled, and sealed in a manner designed to prevent contamination of their contents..." will depend on the purported quality characteristics of the material under sample and the warehouse environment. For containers or closures purporting to be sterile or depyrogenated, sampling should be under conditions equivalent to the purported quality of the material: a warehouse environment would not suffice . This is to preserve the fitness for use of the remaining containers or closures as well as to ensure sample integrity, if they are to be examined for microbial contamination. At aminimum, any sampling should be performed in a manner to limit exposure to the environment during and after the time samples are removed (i.e., wiping outside surfaces, limiting time that the original package is open, and properly resealing the original package).

*In-Process control procedure* These are checks that are carried out before the manufacturing process is completed. The function of in-process controls is monitoring in order to comply with the specifications .It may include control of equipment and environment too. Rejected in-process materials should be identified and controlled under a quarantine system designed to prevent their use in manufacturing .Written procedure should be established and followed that describe the in-process controls and tests. ✍️IPC TESTS FOR VARIOUS DOSAGE FORMS: 👉Tablets: 1.  Drug contents determination. 2.  Moisture contents of granules. 3.  Assay of active ingredients. 4.  Weight variation of uncoated tablets. 5.  Hardness test. 6.  Disintegration test. 👉SYRUPS AND SUSPENSION: 1.  Drug contents determination. 2.  Assay of active ingredients. 3.  pH. 4.  Weight per ml. 5.  particle size 👉SEMI- SOLIDS: 1.  Drug contents determination. 2.  Assay of active ingredients. 3.  Uniformity and homogeneity test. 4.  Viscosity and specific gravity test. 5.  Filling test. 👉 INJECTABLES: 1.   Clarity test. 2.   pH. 3.   Pyrogen test ( endotoxin test) 4.   osmolality test. 5.   Leakage test. 6.  particulate matters. 7. Assay of active ingredients. References:  21 CFR 211.110 Sampling and testing of in-process materials and drug products. #pharmaceuticalindustry

#HoldTimeStudy #SampleTest Hold time validation involves various tests to ensure that a product or intermediate remains stable and maintains its quality throughout the holding period. The specific tests required depend on the nature of the product and its critical quality attributes. Here are some common tests performed on hold time samples: 1. **Physical Tests**: - **Appearance**: Checking for any changes in color, clarity, or presence of particulates. - **Consistency/Viscosity**: For semi-solid and liquid products to ensure they maintain their physical properties. 2. **Chemical Tests**: - **Assay/Potency**: Measuring the active ingredient(s) to ensure they remain within specified limits. - **Impurity/Degradation Product Analysis**: Checking for the presence and levels of impurities or degradation products. - **pH**: Measuring the pH to ensure it remains within acceptable ranges. 3. **Microbiological Tests**: - **Bioburden**: Testing for microbial contamination. - **Sterility**: For sterile products, ensuring they remain free from microbial contamination. - **Endotoxin Levels**: For injectable products, ensuring endotoxin levels remain within limits. 4. **Packaging and Container Integrity**: - **Seal Integrity**: Ensuring that the packaging maintains its integrity and prevents contamination. - **Closure System Testing**: Checking that the container-closure system maintains its performance over the hold time. 5. **Other Specific Tests** (depending on product type): - **Dissolution Testing**: For solid dosage forms like tablets and capsules. - **Moisture Content**: For hygroscopic materials to ensure they do not absorb excessive moisture. - **Oxygen Content**: Using headspace analysis for products sensitive to oxidation. ### References 1. **ICH Guidelines**: - **ICH Q1A(R2)**: "Stability Testing of New Drug Substances and Products". Available from: [ICH.org](https://lnkd.in/eP6KnfHM) 2. **FDA Guidance**: - **FDA Guidance for Industry: Process Validation: General Principles and Practices**. Available from: [FDA.gov](https://lnkd.in/eDkP8WYY)

🔗 Ensuring GMP Compliance in Pharmaceutical Water Systems: A Critical Step for Product Quality In pharmaceutical and biotechnological industries, maintaining a robust GMP-compliant water system is crucial for ensuring product safety and efficacy. As we know, water is a key ingredient in many formulations, and its quality directly impacts the final product. Proper production, storage, and distribution of pharmaceutical-grade water (such as WFI and Purified Water) are essential for maintaining compliance with regulatory standards to assure safe drugs for patients. 💧 Key Considerations for Water Systems: 1. Water Quality Control: Continuous monitoring of microbial and chemical contaminants is necessary to meet stringent specifications. 2. Controlled Storage: GMP demands that water be stored in a way that prevents contamination, including temperature control and minimizing biofilm formation. 3. Efficient Distribution: The design of the distribution system must ensure consistent flow, cleanliness, and prevention of stagnation. 💡 Implementing Contamination Control Strategies (CCS) can help prevent risks, such as microbial growth and endotoxin formation, which are critical concerns in Good Manufacturing Practice (GMP). RMM techniques help in making Contamination Control practices fast and reliable. 🔬 Regular audits, validation processes, regular maintenance driven by preventive and predictive practices and adopting cutting-edge technologies are vital in optimizing water systems and keeping up with industry standards. Let’s continue to prioritize water quality as a cornerstone of patient safety and product integrity. #PharmaceuticalWater #GMPCompliance #Biotech #WaterSystems

#candy, dissolution rates may be significantly slower, even with the use of agitation and heat ⚠️ The 2nd issue involving solubility is whether the contaminant, as it exists in the equipment to be cleaned, has been significantly altered such that it is no longer readily soluble 📚 For example, the heat used in #pharmaceutical processing may #chemically alter the contaminating residue so it is no longer #water_soluble 📚 Continuing with the example of sugar, the sugar may become "caramelized" #polymerized during processing and form a relatively water-insoluble material on equipment surfaces. 📚 Using water to clean the equipment, even with adequate #agitation at elevated #temperatures, may no longer serve to remove the sugar residues adequately 🎄 In #designing a cleaning solution that will dissolve the residue, which residue is targeted❓ Unless all #chemical species are soluble in the selected solvent (water/an organic solvent), solubility may not be the best cleaning mechanism to select if it is the #sole cleaning mechanism #quality #validation #contamination #productdevelopment #qualification #cleanroom #manufacturing #cleaningvalidation #processdevelopment #qbd #processvalidation #Cleaning_Validation #Validation #Process_Validation #Pharma #quality #validation #pharmaceutical #contamination #drug #productdevelopment #pharmaceuticalindustry #qualification #cleanroom #cleanliness #pharma #manufacturing #environment #design #cleaningvalidation #processdevelopment #qbd #processvalidation #pharmaceuticalengineering #pharmaceuticalmanufacturing #qualityassurance

STANDARD OPERATING PROCEDURE ON COLLECTION AND HANDLING OF CONTROL SAMPLE A control sample refers to a specific amount of material - it can be a starting material, packaging material, drug substance, or even the final drug product itself - collected from a particular batch. This sample is then stored under controlled conditions throughout the shelf life of the batch. https://lnkd.in/gwNVSGta

𝐂𝐥𝐞𝐚𝐧𝐢𝐧𝐠 𝐕𝐚𝐥𝐢𝐝𝐚𝐭𝐢𝐨𝐧 #Cleaning_validation is a critical process in #pharmaceutical_manufacturing. It ensures thorough #cleaning_of_equipment and #facilities to prevent #cross_contamination and maintain product quality and safety. 📌 𝑻𝒚𝒑𝒆𝒔 𝒐𝒇 𝑪𝒍𝒆𝒂𝒏𝒊𝒏𝒈 𝑽𝒂𝒍𝒊𝒅𝒂𝒕𝒊𝒐𝒏: 📍𝐷𝑒𝑡𝑒𝑟𝑔𝑒𝑛𝑡 𝐶𝑙𝑒𝑎𝑛𝑖𝑛𝑔 𝑉𝑎𝑙𝑖𝑑𝑎𝑡𝑖𝑜𝑛 Focuses on effective removal of #cleaning_agents (detergents) to prevent #contamination. 📍𝑃𝑟𝑜𝑑𝑢𝑐𝑡 𝑅𝑒𝑠𝑖𝑑𝑢𝑒 𝐶𝑙𝑒𝑎𝑛𝑖𝑛𝑔 𝑉𝑎𝑙𝑖𝑑𝑎𝑡𝑖𝑜𝑛: Verifies removal of #residues from previous products to prevent cross-contamination. 📍𝐵𝑖𝑜𝑏𝑢𝑟𝑑𝑒𝑛 𝐶𝑙𝑒𝑎𝑛𝑖𝑛𝑔 𝑉𝑎𝑙𝑖𝑑𝑎𝑡𝑖𝑜𝑛: Ensures elimination of #microbial_contaminants during cleaning. 📍𝐸𝑛𝑑𝑜𝑡𝑜𝑥𝑖𝑛 𝐶𝑙𝑒𝑎𝑛𝑖𝑛𝑔 𝑉𝑎𝑙𝑖𝑑𝑎𝑡𝑖𝑜𝑛: Validates removal of #pyrogenic_substances (#endotoxins) to prevent product contamination. 📍𝐶𝑙𝑒𝑎𝑛𝑖𝑛𝑔 𝐴𝑔𝑒𝑛𝑡 𝑅𝑒𝑠𝑖𝑑𝑢𝑒 𝐶𝑙𝑒𝑎𝑛𝑖𝑛𝑔 𝑉𝑎𝑙𝑖𝑑𝑎𝑡𝑖𝑜𝑛: Ensures removal of cleaning agent residues like solvents and detergents. 📍𝑆𝑤𝑎𝑏 𝑆𝑎𝑚𝑝𝑙𝑖𝑛𝑔 𝐶𝑙𝑒𝑎𝑛𝑖𝑛𝑔 𝑉𝑎𝑙𝑖𝑑𝑎𝑡𝑖𝑜𝑛: Uses physical swabbing and analysis for #residual_contaminants. 📍𝑅𝑖𝑛𝑠𝑒 𝑆𝑎𝑚𝑝𝑙𝑖𝑛𝑔 𝐶𝑙𝑒𝑎𝑛𝑖𝑛𝑔 𝑉𝑎𝑙𝑖𝑑𝑎𝑡𝑖𝑜𝑛: Rinses equipment and analyzes rinse solutions for contaminants. 📍𝑉𝑖𝑠𝑢𝑎𝑙 𝐼𝑛𝑠𝑝𝑒𝑐𝑡𝑖𝑜𝑛 𝐶𝑙𝑒𝑎𝑛𝑖𝑛𝑔 𝑉𝑎𝑙𝑖𝑑𝑎𝑡𝑖𝑜𝑛: Involves detailed visual examination for cleanliness. 📍𝐴𝑛𝑎𝑙𝑦𝑡𝑖𝑐𝑎𝑙 𝑇𝑒𝑠𝑡𝑖𝑛𝑔 𝐶𝑙𝑒𝑎𝑛𝑖𝑛𝑔 𝑉𝑎𝑙𝑖𝑑𝑎𝑡𝑖𝑜𝑛: Employs analytical methods (e.g., HPLC, GC, MS) to detect and quantify contaminants. 📍𝑀𝑎𝑡𝑟𝑖𝑥𝑖𝑛𝑔 𝑎𝑛𝑑 𝐵𝑟𝑎𝑐𝑘𝑒𝑡𝑖𝑛𝑔 𝐶𝑙𝑒𝑎𝑛𝑖𝑛𝑔 𝑉𝑎𝑙𝑖𝑑𝑎𝑡𝑖𝑜𝑛: Validates multiple similar products or equipment with reduced runs. 📍𝑊𝑜𝑟𝑠𝑡-𝐶𝑎𝑠𝑒 𝑆𝑐𝑒𝑛𝑎𝑟𝑖𝑜 𝐶𝑙𝑒𝑎𝑛𝑖𝑛𝑔 𝑉𝑎𝑙𝑖𝑑𝑎𝑡𝑖𝑜𝑛: Conducted under challenging conditions, using worst-case scenarios for #residues and #processes. ✅ #Cleaning_validation ensures compliance with regulatory standards and quality assurance, safeguarding #pharmaceutical_product_integrity and patient safety. Different types are employed based on specific cleaning needs and #contaminants.

Discover the Leading Liquid Injection Manufacturers in Baddi with Dr. Darwin Lab Today. WHO GMP Certified Approved Units Get quote:- https://lnkd.in/g4bTTAZr... #drdarwinlab #injection #injectionrange #injectionmanufacturers #pharmamanufacturers #injectionmanufacturing #injectable #baddi

🔍 𝗗𝗜𝗗 𝗬𝗢𝗨 𝗞𝗡𝗢𝗪 cGMP stands for Current Good Manufacturing Practice, a vital component in the supplement industry... At AMP Nutra, we adhere to cGMP standards to ensure every product meets the highest quality and safety benchmarks. 𝗧𝗵𝗶𝘀 𝗿𝗶𝗴𝗼𝗿𝗼𝘂𝘀 𝗽𝗿𝗼𝗰𝗲𝘀𝘀 𝗶𝗻𝘃𝗼𝗹𝘃𝗲𝘀: 𝘘𝘶𝘢𝘭𝘪𝘵𝘺 𝘔𝘢𝘯𝘢𝘨𝘦𝘮𝘦𝘯𝘵: Systems in place to oversee all manufacturing stages. 𝘍𝘢𝘤𝘪𝘭𝘪𝘵𝘺 𝘢𝘯𝘥 𝘌𝘲𝘶𝘪𝘱𝘮𝘦𝘯𝘵: Regularly maintained to prevent contamination. 𝘙𝘢𝘸 𝘔𝘢𝘵𝘦𝘳𝘪𝘢𝘭𝘴: Sourced from trusted suppliers and tested for purity. 𝘗𝘳𝘰𝘥𝘶𝘤𝘵𝘪𝘰𝘯 𝘊𝘰𝘯𝘵𝘳𝘰𝘭𝘴: Detailed documentation to trace the journey of each product. 𝘓𝘢𝘣 𝘛𝘦𝘴𝘵𝘪𝘯𝘨: Verifying product integrity before it reaches you. 💡 𝗧𝗶𝗽 𝗳𝗼𝗿 𝗕𝘂𝘀𝗶𝗻𝗲𝘀𝘀𝗲𝘀 When selecting a supplement manufacturer, always inquire about their cGMP compliance. It's your assurance of quality and safety.

🔍 𝘈𝘳𝘦 𝘠𝘰𝘶𝘳 𝘘𝘊 𝘓𝘢𝘣 𝘙𝘦𝘴𝘶𝘭𝘵𝘴 𝘢𝘵 𝘙𝘪𝘴𝘬 𝘋𝘶𝘦 𝘵𝘰 𝘖𝘷𝘦𝘳𝘭𝘰𝘰𝘬𝘦𝘥 𝘙𝘦𝘢𝘨𝘦𝘯𝘵 𝘌𝘹𝘱𝘪𝘳𝘺 𝘋𝘢𝘵𝘦𝘴? 🧪 The accuracy of your analytical results is only as good as the reagents you use. Whether sourced commercially or prepared in-house, managing their expiry dates is crucial—not just for compliance, but for the integrity of your entire testing process. ❗ Why it Matters: - 𝐀𝐜𝐜𝐮𝐫𝐚𝐜𝐲 & 𝐑𝐞𝐥𝐢𝐚𝐛𝐢𝐥𝐢𝐭𝐲: Degraded reagents can skew your data, leading to inaccurate results that undermine your lab's integrity. - 𝐒𝐚𝐟𝐞𝐭𝐲: Expired reagents may become unstable, posing risks to both your team and your outcomes. 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞: Strict adherence to reagent expiry dates is not just best practice—it's a regulatory requirement. 🔍 Best Practices: - Regularly assess reagent stability, especially after containers are opened. - Follow manufacturer guidelines and OMCL’s standards for determining shelf life. - Implement robust documentation and labeling systems to track expiry dates effectively. Effective management of reagent expiry dates means regular stability testing, proper storage, and strict adherence to guidelines. By doing so, you ensure that your lab maintains the highest standards of quality and reliability. 💼 Read more about it in our newest article: https://lnkd.in/eKutX-hX #GMPInsiders #Pharma #QualityControl #LabExcellence #DataIntegrity #ReagentManagement #OMCL