ELABORATE & COMPLETE IN- PROCESS CONTROL:
"Quality isn't something that can be argued into an article or promised into it. It must be a culture and must be one of the key ingredients of the manufacturing processes. Otherwise, the finest sales talk in the world won't act as a substitute."
SIMPEX firmly believes in the fact that Quality stems from an attitude of refusing to settle for the second best, leaving no room for compromise. The approach to Quality Control is total and integrated.
Quality Control/Assurance checks at all stages of production commencing from bulk drugs including excepients to the finished formulations. Chemicals, microbiological analysis testing like microbial count, instrumental analysis using highly sophisticated as well as modern instruments like HPLC, GC, UV, are conducted as per specified pharmacopeial criteria.
Quality review programmes including stability studies as per ICH guidelines are methodically followed. Documents like BMR, MFR, SOPs support implementation & maintenance of cGMP at all our manufacturing sites. Methods & Process Validation Regular Self-inspection, and Quality Audit form integral part of our Quality Management prerogative. Monitoring of Environment Controls within and outside manufacturing plants & Safety measures of our employee staff is the keystone of our safety management plan and forms the 'Quality Bible' of the company.
VALIDATION & QUALIFICATION APPROACH OF MANUFACTURING AND TESTING EQUIPMENT & INSTRUMENTS:
Design: This is synonymous with Development, Characterisation. In SIMPEX this block includes the project design, User Requirement Specification, Functional design Specification, Design Qualification, Process Development & Characterisation.
Build: Synonymously used as Installation, this block encompasses the Installation Qualification of Equipments, project erection, facility built up & Room Qualification.
Operate: This block encompasses the Operational Qualification of the equipment, area, systems, utility.
Perform: Synonymously used as verification/evaluation is the phase of extensive testing of the entity being validated often at challenging conditions known as ‘Worst Case’. This is the phase when a system/process is considered as ‘in validated state’ and an equipment ‘in qualified state’ if the evaluation of the validation /qualification performed are satisfactory and meeting the acceptance criteria.
Maintain: Maintenance of the entity in the validated condition is the significant activity after the system performance is established. This necessitates close monitoring and control of the variables that tend to alter the ‘State of Validation’ of the Entity. This shall be achieved by proper execution of Quality System Tools like Change Control, Deviation Control, Investigation of Failures and Trend Analysis. The Preventive Maintenance as well as Breakdown Maintenance shall be designed and executed in order to maintain the State of Validation.
Close : When finally, for whatever reasons, the entity (Process/system/method) is to stop being used or the facility /equipment is to be replaced (decommissioning) the validation activity shall be closed. Necessary documentation of Closure Qualification like obsoleting the master documentation associated with the entity like MFR, BMR, BPR, updation of the Master Lists for equipments, Equipment History Card,SOPs , Specifications, STPs shall be done and shall be archived.
Full - Fledged Quality Tools & Total Quality Control:
The dedicated Quality Control laboratory facilities at manufacturing location is technologically advanced and supported by sophisticated analytical instruments. The synchronization of QC processes, skillful Tehnicians sophisticated analytical tools and quality assurance protocol ensures that every product quality not only meets but surpasses international standards.
All QC Laboratories confirm to cGLP (current Good Laboratories Practices) in Total Quality Management. Achievement of this standard is manifestation of the highly systematic and documented work culture that we are committed to follow.
The award of GMP certificate and preparedness to USFDA, TGA & UK MHRA quality norms in our manufacturing venture, further corroborates our quality commitment.