Quality is built-in and sustained right from development to commercial dispatch. This is achieved by deploying actions under two major heads:

• Development Quality Assurance (DQA) – R&D
• Quality Assurance (QA) – Commercial

Development Quality Assurance takes care of the development-related functions by ensuring that the right product is developed, which is safe, pure and efficacious. In addition to this, they also make sure that the processes are scalable in the commercial sense, so that we get a consistent quality product. Each product goes through a stage gate defined as workflows on a project management basis. Some of the key criteria built into development are ensuring quality products, and low-cost, user- and environment-friendly processes. For example, usage of Class I type of solvents is avoided due to the significant impact on the environment as well as human health.

On the commercial side, the Quality Assurance function assures quality standards are maintained right until the product reaches the patient. It comprises the following groups to achieve a robust Quality Management System:

• Manufacturing Assurance
• Analytical Assurance
• Engineering Assurance
• Documentation Assurance

There are detailed and robust standard operating procedures for each type of system to ensure there is uniformity and consistency in the work done. To name a few, we have Market Complaint Handling, Incidents, Deviations, Change Control, Vendor Management, Self Audits, Training and Documentation. Each individual is trained on these systems and on Good Manufacturing Practices before being put on the job.

Every product goes through the validation cycle to ensure consistency. On a routine basis, there are in-process checks followed by detailed Quality Control testing, which ensures that quality products are delivered.

The effectiveness is checked by means of Audits carried out by internal teams through a self inspection process, and also by the Audit and Compliance team.

Driving Quality Excellence in PSAI
For competency and skill building, in-house training workshops were initiated using our internal resource pool – ‘Learning Curve’. New recruits from cross-functional teams undergo extensive training on ‘Quality in Dr. Reddy’s’.

One of the highlights of the past year was the launch of eBPR (Batch Production Record), a user friendly and versatile tool of process documentation which helps prevent operational errors and saves time.

Across locations, a dedicated team for Audits was set up to coordinate with Plant Heads, Site Quality Assurance, Quality Control, and Regulatory Affairs & Technical Services Department for harmonized systems. Audit Observations are reviewed and responded to, by the central team to get a focused approach on root cause analysis and improvements.

A dedicated team for handling customers’ complaints was created to keep track of response timelines, and the quality of investigation.

At Dr. Reddy’s, Quality and Compliance are our main business goals – and these are the responsibility of every employee.

A number of processes in manufacturing have been automated to reduce the chances of human error in our functioning. We also have stringent procedures to assess the impact of errors and to take steps to prevent these from happening again.

We have in-process checks at critical stages to ensure that product manufacturing is heading in the right direction. We aim to ensure that every step in our processes is done ‘first time right’. . This is why we have independent Doers and Checkers at various stages. Doers hold greater accountability as only they can get the job done right the first time, while, equally important, the Checker has to detect if anything has gone wrong. For this reason, we place a great emphasis on the induction programs and on-the-job training for our people, so that they are well-equipped with the right skills and knowledge to follow the correct procedures.

Another recent development at Dr. Reddy’s is the introduction of Focused Teams that concentrate on doing only one job at a time. This has resulted in better prioritisation during the development stage itself, and has helped reduce the scope for errors.

All the teams are encouraged to report any non–conformances, which in turn, get addressed by written systems and procedures that are in place.

We have processes to ensure continuous improvement, a few of which are:

• a corrective action and preventive action process (CAPA), which is triggered in the event of any incident or audit findings
• learning from experience gathered through routinely conducted external training by experts in the field, like machine manufacturers and industry experts

The Quality function at Dr. Reddy’s also constantly reviews and improves vendor management processes, to ensure consistent quality of inputs and raw materials.

Material Sourcing Quality Assurance group
Many of our Key Starting Materials are sourced through single vendors. QA / QC support has been extended and a dedicated team was set up to support alternate vendor development processes. The Material Sourcing Quality Assurance group (MSQA) successfully implements Dr. Reddy’s Quality and Regulatory initiatives at Strategic Business Partner sites to constantly ensure that manufacturing and supply of key raw materials meet regulatory requirements.

Through the model of Contract Manufacturing and Strategic Sourcing, MSQA works for the continuous development of selected partners.

Following are the key achievements of the group over the year:

Evaluation and approval of 59 new / alternate sources in the last year

• Qualified five new strategic business partners and supported the improvement in performance
• Streamlined standard procedures for technology transfers, process changes, failure investigations and complaints management
• Successfully coordinated audits from international customers at SBP sites
• Arranged technical training programs at SBP locations and collective seminars at Dr. Reddy’s, as a part of continuous development and learning

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