Quality Control Laboratory

Quality control in Mark Formulations is fully equipped with sophisticated instrument (HPLC, UV, Karl Fischer Titrator, Stability chamber with 24 hr electricity backup , five-digit sensitive balance, latest BOD incubator, LAF, Dissolution Tester,Latest Autoclave, Water purifier for HPLC analysis purpose  etc., with many have 21 CFR compliant) along with presence of well qualified personnel

Our Quality Control mainly focuses on:

• Sampling, analysis of raw materials and packaging materials

• Analysis of product at various stages of productions
• Stability studies and retention sample management
• Active and Inactive ingredients are analyzed as per pharmacopoeia / in-house method
• Artworks for labels, cartons, inserts and other packaging materials are approved for correctness by QC before its printing and usage
• Maintenance of GLP
• Chemical and microbiological test for water

Quality Assurance and Regulatory Affairs

Mark Formulations always committed on the quality product, we strictly follow the existing act, regulation, code, policies, directives and guidelines of the regulatory body regarding drugs ensuring our product safe, effective and quality. Quality Assurance(QA) Department holds the prime responsibility of generating systems and procedures and their control, monitoring of compliance to GMP requirement, monitoring and control of the manufacturing environment and handling of products related. Furthermore, we are very concerned of safety of our working personnel.

Our QA Department mainly focuses on:

• Documentation control (from initial to end of batch)
• Qualification, Validation, Calibration program
• Quality improvement plan (Annual product quality reviews, complaint handling, CAPA, Trend analysis of various product parameters and water, Change control)
• Training (GMP, GLP, safety rules)
• Ensure implementation and Complies with Regulatory bodies rules and regulation (Manufacturing license, Marketing license, import license, inspection, quality audit)  
• Communication and coordination with all department present within organization
• Vendor audit.

Manufacturing

Manufacturing department in Mark Formulation holds the prime responsibility for the manufacturing of quality products in controlled conditions as per BMR and BPR and following the respective SOPs and strict control on documentation system. Production department is well equipped with latest novel technology such as Autocoater, Alu-Alu Packaging Machine,  RMG, FBD, Capsule Filling Machine, Liquid filling etc with validated latest GMP model and motivated qualified personnel.

Our production department mainly focuses on:

• Manufacturing (different dosage form: liquid, tablet, capsules ,ointment and dry syrup)
• Ensuring that all equipment is correctly utilized and validated
• Sanitation and hygiene (all personnel’s and equipment’s)
• Reviewing all batch manufacturing record and batch packing records
• Provide overall direction for technical and administrative operation in different section of products

Engineering and Maintenance

Mark Formulations has independent department of Engineering and Maintenance consisting of qualified and well experienced personnel for operation of novel and automated machine present in our industry.

Our Engineering and Maintenance department mainly focus on:

• Repair and maintenance of all machineries, equipment and instrument
• Qualification/ requalification of equipment
• Follow the safety procedure to ensure the safe of working personnel
• Mobilize the maintenance team in production area and remain standby in breakdown to reduce the stoppage time of production
• Trace the consumption of water and electricity
• Running and monitoring of utilities (ETP, HVAC, Compressed Air, Generator, Latest Water Purification system) regularly or periodically  

We are very concerned to conservation of our eco-system that’s why for ensuring it, we treat all effluent (ETP) before it get mixes to the sewage.