Production

A high-performance workplace results from continually balancing investment in people, process, physical environment and technology, to measurably enhance the ability of workers to learn, discover, innovate, team and lead, and to achieve efficiency and financial benefit.

Handling of materials:

 All materials are purchased from approved suppliers with GMP certificate.All incoming materials are visually checked for signs of damage to the containers. Details of the delivery are checked against relevant purchase orders. Containers are cleaned before entry into the warehouse.The materials are labeled appropriately and quarantined in designated areas.A Material Receipt Note (MRN) is prepared and sent to QC to initiate sampling. Sampling is done QC personnel. A unique Analytical Reference (AR) number is assigned to the lot or batch for the purposes of identification and traceability. After analysis, materials are passed or rejected and labeled appropriately.Only starting materials which have been released by QC and which are within the retest period are used.Dispensing is done by designated persons who ensure that the materials are accurately weighed into clean and properly labeled containers. Each dispensed material and its weight is independently checked and recorded.Materials dispensed for each batch are kept together and labeled accordingly.

Handling of Rejected Materials and products:

Rejected materials and products are clearly marked and stored separately in a segregated area.They are either returned to the suppliers, reprocessed or destroyed.Records are maintained.

Rejected materials and products are clearly marked and stored separately in a segregated area.They are either returned to the suppliers, reprocessed or destroyed.Records are maintained.

Process Validation

Validation studies as per protocol are carried out periodically by nominated teams comprising personnel from various disciplines.The approved validation protocol includes acceptance criteria, controls for critical parameters,validated test procedures, equipment calibration data, operating procedures, assessment of results, conclusions and recommendations.Signified amendments to the manufacturing processes, including any change in equipment or materials, are validated. All validation and re validation are documented.

A high-performance team is a group of people with specific roles and complementary talents and skills, aligned with and committed to a common purpose, who consistently show high levels of collaboration and innovation that produce superior results.The high-performance team is regarded as tight-knit, focused on their goal and have supportive processes that will enable any team member to surmount any barriers in achieving the team’s goals.Within the high-performance team, people are highly skilled and are able to interchange their roles.Also, leadership within the team is not vested in a single individual. Instead the leadership role is taken up by various team members, according to the need at that moment in time. High-performance teams have robust methods of resolving conflict efficiently, so that conflict does not become a roadblock to achieving the team’s goals. There is a sense of clear focus and intense energy within a high-performance team.Collectively, the team has its own consciousness, indicating shared norms and values within the team. The team feels a strong sense of accountability for achieving their goals.Team members display high levels of mutual trust towards each other.