QUALITY MEASURES ISO 9002
Pulse Quality Management Systems philosophy as expressed and authorized by top management outlines the general principles of quality assurance and quality control. It is considered as joint responsibility of the C-Level reinforcement, middle management support and all team member compliance for production of quality medicines. Emphasis on Hygiene, Validation, Self-Inspection, Personnel, Premises, Equipment, Material & Documentation.
Pulse Management desires strict environmental controls to reduce chances of particulate and microbial contamination. The premise of pharmaceutical factory is constructed in such a way as to reduce chances of introduction, generation, and retention of contaminants within the area. Premises provide complete and total separation of all aspects of an operation, including personnel and equipment movement, with well established procedures, controls and monitoring. This includes physical barriers as well as separate air-handling systems within the environment
QUALITY CHECK ON CONTAMINATION/CROSS CONTAMINATION
Pulse Quality & Inspection Team performs continuous industrial and pharmaceutical checks to put control on Contamination/ Cross- Contamination from undesired introduction of impurities of a chemical or of microbiological nature, or of foreign matter, on starting material or intermediate stages during production, sampling, packaging or repackaging, storage or transport.
Pulse Pharmaceutical Quality Department performs checks during production in order to monitor if necessary, to adjust the process to ensure that the product conforms to its desired specifications. The regular control of the environment or equipment is regarded as a part of in-process control as defined in Pulse quality Policy.
Pulse enforces strict quarantine policy from starting or packaging materials, intermediates, or bulk or finished products through isolation physically or by other effective means till their release, rejection or reprocessing.
SANITATION AND HYGIENE
Pulse maintains documented and defined policy for Sanitation & hygiene for all employees specifically performing checks on those employees, workers involved in different stages of the production. Personnel, Premises, Equipment and apparatus, production materials and containers, products for cleaning and disinfection, and anything that could become a source of contamination to the product. Potential sources of contamination to be eliminated through an integrated comprehensive programme of sanitation and hygiene
QUALITY CONTROL & ASSURANCE
Quality control is an essential operation of the pharmaceutical industry. Quality Control standards at Pulse Pharmaceuticals narrate drugs to be marketed as safe and therapeutically active formulations, whose performance is consistent and predictable. New and better medicinal agents are being produced and evaluated through more exacting and sophisticated analytical methods. All requirements governing the quality control of pharmaceuticals in accordance to regulatory standards are met with periodic checks for verification and validation purposes.
Pulse’s Quality assurance methodology is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use.
SELF-INSPECTION AND QUALITY AUDITS
Pulse Pharmaceuticals on self-inspection and quality audits is clear and definitive to ensure on manufacturer’s compliance to regulatory standards for all phases of production and quality control. The self-inspection purpose is to detect any shortcomings in implementation of good manufacturing principles and to recommend the necessary corrective actions. Self-inspections are performed routinely, or any time before an inspection by the health authorities or in case of repeated rejection of products. Our Self-Inspection team consists of personnel with professional ability to evaluate the implementation of production requirements objectively. Corrective and Preventive actions in form of report are documented to be followed as recommended.
Pulse Pharmaceuticals is an ISO 9001:2000 certified company which mandates them to have clearly defined company-wide policies, procedures and processes for performing operations not necessarily specific to a given product or material (e.g. equipment operation, maintenance and cleaning; validation; cleaning of premises and environmental control; sampling and inspection) but to ensure the company maintains quality standards on anything and everything done.