AGONIST PHARMACEUTICALS PVT. LTD. is specialized, research and development based pharmaceutical company that is built to explore and achieve new dimensions in healthcare sector. We are manufacturing and marketing wide range of pharmaceutical products across various geographies to counteract different disease and spread healthness everywhere. AGONIST PHARMACEUTICALS PVT. LTD. focuses that all its service and products must finally meet the needs of customer or patient with quality product. We are accredited with ISO 9001:2015 certification. The production of edicines is taken to the highest of standards so as to produce maximum improvement in the health of ailing patients. Our success is strongly rooted in our belief of Quality Products, Timely Supplies and Transparent Dealings.
Production
Type of products
The company has applied for license to manufacture Tablets, Capsules and Oral Liquid General category.
Every process flow has process-points that describe processing steps. The process flow is divided into several steps/ stages, such as material receiving step, intermediate product stage,intermediate bulk stage, primary and secondary packaging steps and finished product delivery step. Every stage will go through inspection process according to acceptance criteria determined by QA Department.
Flow diagram for manufacturing process is attached Separately.
Process validation
- First three consecutive batches of each product shall be validated to ensure that the manufacturing process consistently produces the product to meet the pre-determined specifications. Any change, thereafter is through change control approval. If the change asks for revalidation of process, the same is again carried out. Validation activities shall be executed through approved protocols and SOPs shall be strictly adhered. SOP shall take precedence over protocol for all compliances.
- Process is considered for validation, whenever there is a technology transfer of a product from Formulation development or from the product owner to the manufacturing site. Process Validation is applicable for the following occurrences:
- When new product is manufactured.
- Existing product undergoes a change in process, formula, source of active ingredient or equipment.
- The results of critical parameters are not found within predetermined specification.
- The results of the various activities shall be recorded. Based on these results, a validation report shall be prepared and a conclusion arrived at after review of the results.
- The process is termed validated if defined process meets all the acceptance criteria as mentioned in the protocol. The validation protocol along with the report shall be maintained by Quality Assurance after approval of the report. If at any stage, the process is found to be unacceptable, then a suitable corrective action shall be initiated.
Plant & Machinery
Medicines are meant for saving lives and cure it but any negligence or deliberate duplicity may cause serious health hazard up to the extent of death. The whole up to the extent of death. The whole manufacturing process is undergone under the supervision of experienced quality control team so that there remains no scope of malfunctioning. Plant is designed and constructed as per WHO GMP standard having dedicated areas for each operation. We have RMGs, FBDs, blenders, double rotary compression machines, capsule filling machine and Alu-Alu, Blister & strip packing machines for tablet and capsule sections. We have automatic oral liquid filling line for syrups & suspensions.
Storage Facility
We have enough storage facility to hold huge stock of products. The warehouses are well-furnished and well-equipped to sustain the quality standard during the storage period. We have been, therefore, able to maintain a brilliant track record of timely supply.
Quality System
We believes that quality is soul of Pharmaceutical Formulation Company. Aim of quality system is to ensure that standard quality products are manufactured in quality environment using standard operating processes and materials. To achieve this goal comprehensive quality system is implemented where by each and every material, process, procedure and activity is standardized, validated & documented. Quality Assurance and Quality Control departments are heart of our quality system.
Our Quality Assurance Department is responsible for formulating and implementing quality system. It also investigates shortcoming of system and take preventive and corrective actions as may be required. Quality Control department analysis APIs, excipients, primary & secondary packing materials, semi-finished & finished formulations and water quality for integrity of the final product. We have in house Physico —Chemical, Instrumental & Microbiological testing labs equipped with state of the art instruments. To assure stability of the product stability studies are carried out on regular basis.
Regulatory & Compliance Support
Under Quality Assurance and Quality Control department well qualified and experienced person takes care of regulatory work. We are capable for supporting registration process and other regulatory documentation as per the needs of concern country. We support our associates by providing dossiers as per CTD, ACID and specific country guidelines. We have several dossiers ready for fast pace product registration.
Our facilities are constantly upgraded to comply with CGMP norms. Formulation development cell is engaged in new formulation development on regular basis. Routinely internal audits are carried out for constant upgradation of facility and procedures to meet contemporary international quality standards. Deviations in process and products are recorded and promptly complied.