At Genius Herbs (www.dietarysupplementsindia.com ) we adhere to the following steps in manufacturing of herbal products which involves several stages to ensure quality, safety, and efficacy. The specific stages may vary depending on the type of herbal product and the manufacturing processes used. Here is a general outline of the typical stages in herbal product manufacturing we use.
• Identify and source high-quality raw materials, such as herbs, plants, or plant extracts, from reputable suppliers.
• Ensure that the raw materials meet quality standards and comply with regulatory requirements.
• Perform various tests on raw materials to assess their identity, purity, potency, and quality.
• Common tests may include organoleptic testing, microscopic analysis, chemical assays, and microbial testing.
• Extract the active constituents from the raw materials using appropriate methods, such as solvent extraction, steam distillation, or cold pressing.
• Process the extracts to obtain the desired concentration and consistency.
• Combine different herbal extracts or other ingredients according to a specific formulation to achieve the desired therapeutic effect.
• Add any necessary excipients or carriers to enhance stability and bioavailability.
• Weigh and measure the individual components based on the formulation.
• Mix the ingredients thoroughly to ensure homogeneity.
• Granulate the mixture to create uniform particles, especially for tablet or capsule formulations.
• Form the herbal mixture into tablets or fill capsules using appropriate equipment.
• Ensure that the final dosage forms meet quality and consistency standards.
• Dry the finished products to remove excess moisture, ensuring stability and preventing microbial growth.
• Apply coatings to tablets or capsules for taste-masking, delayed release, or other purposes.
• Perform rigorous quality control checks on the final products.
• Conduct tests for identity, potency, purity, and microbial contamination.
• Package the herbal products in appropriate containers that protect them from environmental factors.
• Label the products with accurate information, including dosage instructions and warnings.
• Store the finished products under proper conditions to maintain their quality.
• Distribute the products to wholesalers, retailers, or directly to consumers.
Genius Herbs (www.dietarysupplementsindia.com ) Good Manufacturing Practices (GMP) Here are some key aspects of Good Manufacturing Practices we follow:-
• Maintain detailed and accurate documentation of all manufacturing processes, including batch records, standard operating procedures (SOPs), and testing records.
• Keep records for traceability and to demonstrate compliance with GMP requirements.
• Train personnel adequately to perform their assigned tasks.
• Ensure that employees are aware of GMP requirements and follow proper hygiene practices to prevent contamination.
• Establish and maintain manufacturing facilities that are clean, well-maintained, and suitable for the production of the specific products.
• Regularly calibrate and maintain equipment to ensure accuracy and reliability.
• Source raw materials from approved suppliers and ensure they meet defined quality standards.
• Implement procedures for the storage, handling, and identification of raw materials to prevent mix-ups and contamination.
• Follow approved and validated manufacturing processes to ensure consistency and reproducibility.
• Monitor critical process parameters to control and optimize the production processes.
• Conduct thorough testing and quality control checks at various stages of production to ensure that products meet specifications.
• Implement procedures for the rejection of substandard or non-compliant products.
• Ensure that packaging and labeling materials are of appropriate quality and meet regulatory requirements.
• Verify that the correct labels are applied to each product, providing accurate information on usage, dosage, and warnings.
• Establish proper storage conditions to prevent deterioration of products.
• Implement controls to ensure that products are stored and transported under conditions that maintain their quality.
• Establish procedures for handling customer complaints and conducting investigations.
• Develop and implement a product recall system in case of identified quality issues.
• Validate critical processes to ensure that they consistently produce products meeting predetermined specifications.
• Qualify equipment to ensure that it is suitable for its intended purpose.
• Implement procedures for managing changes to processes, equipment, or materials to prevent unintended consequences on product quality.
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