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:
Build: Synonymously used as Installation, this block encompasses the Installation Qualification of Equipments, project erection, facility built up & Room Qualification.
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.
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.