BAKSON QUALITY CONTROL LABORATORY

Bakson’s range of products include various pharmaceutical dosage forms such as tablets, liquid orals, ophthalmic preparations, ointments, gels as well as cosmeceutical skin, hair and oral care range apart from Nutritional supplements. Our manufacturing operations are carried out under the most controlled environments where quality is paramount. With cutting edge machinery & excellent quality control, we work to ensure that manufacturing is carried out in a safe and reliable manner in compliance with GMP standards. We are continuously working in house at each step of manufacturing process with precision so as to have no compromise on quality and efficacy of finished products.

We have an in-house quality control laboratory and microbiology laboratories that are equipped with chemical instruments and other instruments for conducting various quality tests on our range of cosmo pharmaceutical products. The general methods of tests conducted by our quality department for raw materials- herbs & chemicals as well as finished products of drugs and pharmaceuticals include Physicochemical and Microbiological tests. The laboratory is equipped with all the basic equipment for physico-chemical analysis, extraction, chemical analysis and assay of chemical compounds by volumetric, gravimetric, spectrophotometric, GLC & TLC techniques. Thin layer chromatography facilities for finger printing of the herbal medicine or the marker compounds that are available for confirming the identity and authenticity of the medicine.

STANDARDIZATION & PURITY CHECKS

These are done by sophisticated procedures like:

• Alkaloidal Assays
• Chromatographic Analysis including Gas chromatography
• Microscopy
• Titrimetric Analysis
• Ultraviolet and Infra red Spectrophotometers

MICROBIOLOGICAL TESTS

• We have a full-fledged Microbiological Laboratory, equipped with the ultramodern equipment that conducts routine and in-depth microbiological testing procedures in order to establish product protocols and in order to validate sterilization processes. For testing bacterial and fungal contamination of herbal material with sterile testing facilities (Laminar flow hood)a full-fledged microbiology section exists. We conduct tests to assess raw materials, as well as bulk and finished formulations. Also, there is a consistent microbiological monitoring of working procedures in process areas and microbiological analysis of products.
• Sterility test
• Water testing
• Equipment cleanliness monitoring
• Sterile area monitoring
• Environmental monitoring of production floor

In order to keep track of all activities, parameters & processes for attaining quality comprehensively, we apply TQM techniques and follow a fully autonomous functionality.

ASSURED QUALITY SPECIFICATION COMPLIANCE

• We maintain written specifications that describe the homeopathic medicine and the required test methods for specifications pertaining to identity, purity, quantity, potency and tolerances.
• Follow conventional testing protocols for each dosage form
• The finished product specifications control the organoleptic and physical characteristics of the product.
• All packaging materials, such as bottles and other materials are stored properly. All containers and closures are thoroughly cleaned and dried before being used to pack the products.
• There are adequate information on the label (or the package insert) to inform the users of the composition of the product, indications, directions for use, cautions and adverse reactions if any, and the expiry date.

We strictly adhere to GLP criteria like:

• Test method reliability: validation and control
• Instrument calibration and maintenance programs
• Reagent and standard quality control
• Authorised materials and product specifications
• Quality, integrity and authenticity of data

Finished Product Auditing – Once a product has been produced, each lot is statistically sampled and finally the product is audited by Quality assurance inspectors for bulk weight, Liquid volume bottle count, Bottle sealing and legible lot number samples are then given to QA labs so that scientists can complete testing according to finished product specifications.

Complaints: The person responsible for handling complaints and deciding on the measures to be taken to deal with them have appropriate training and/or experience in the specific features of the quality control of herbal medicines and the records are available for inspection.

Self-inspection Training

• The personnel have adequate training in appropriate fields such as pharmaceutical technology, taxonomic botany, phytochemistry, pharmacognosy, hygiene, microbiology and related subjects (such as traditional use of herbal medicines).
• Training records are maintained and periodic assessments of the effectiveness of training programmes are made.