Pharmaceutical companies operate in one of the most dynamic and regulated environments. Regulatory audit frequencies have increased. Warning letters and import restrictions incidences have increased alongside. Many companies fail in clearing Regulatory Audits. Failing an audit results in over two years of business loss and huge expenses in achieving success with re-audit.
The Laurel MES product suite for ‘eManufacturing Execution’ is architected and designed for Pharmaceutical Manufacturing businesses to achieve compliance and audit readiness. The product variants, market variants and product changeover challenges are addressed as required. It has emerged as a singular answer to such bottlenecks. With its manufacturing intelligence capabilities, configurability and flexibility, it has the capability to translate valuable data collected into usable information. Management can instantly view dashboards and scorecards to help them make appropriate decisions on a plant or corporate level. This solution is integration-ready for latest manufacturing and testing equipments. This solution works on touch devices and in Pharma Manufacturing environments.
Keeping up with the Latest Technologies
Laurus Infosystems is engaged actively with the team which is responsible for defining Pharma 4.0 standards in line with Industry 4.0.Laurus Infosystems employs Subject Matter Domain Experts from Pharma background. These experts make sure that each of the technical staff also becomes domain experts.
"The Laurel MES product suite for “eManufacturing Execution” is architected and designed for Pharmaceutical Manufacturing businesses to achieve compliance and audit readiness"
The Chemia ELN of Laurus Infosystems has already become leading e Lab Notebook Software. Led by a CEO with strong domain knowledge and an impressive track record of leading Architecture Design and development of software products for Pharma Manufacturing Execution and Pharma R&D, Laurus Infosystems is moving towards achieving gold standard for their revolutionary software products and solutions.
Some of the key findings are:
• Batch manufacturing records are maintained manually in most pharmaceutical companies.
• Manual batch records result in data inconsistency due to human errors and inaccurate timestamp information. These become significant issue with regulatory auditors.
• Failure in dispensing the material using FEFO and FIFO rule results in material getting wasted.
• Failure in timely raw material re-testing results in material getting expired.
• Equipment calibration/maintenance date conflict, with manufacturing date is a challenge.
• The top five reason categories for regulatory audit failures are:
A. Poor Hygiene: Cleaning, Sanitizing, Maintenance and Hygiene Procedures not defined or followed.
B. Poor Control of Environment,
Validation, Calibration, Testing Programs, Reviews and Stability.
C. Poor Batch Controls: Batch Production records not controlled. Data integrity issues. Master formula, Procedure, SOP, QC and CAPA records are not fully controlled.
D. Poor Training & Skills: cGMP knowledge, Training & skills for job missing. Communication is very poor.
E. Lab Controls: Absence of scientifically sound laboratory controls (specs,standards, sampling, procedures etc.).
• Electronic Manufacturing Execution System (eMES) is expected to address most of the above failure reasons. However, very few Indian companies are able to implement eMES in their plants.
• Even those who have implemented the eMES solutions have faced several problems like long turnaround time in introducing new products, high operational costs and difficulty in expanding solution to cover whole of the organization.
• High CAPEX costs and OPEX costs for solutions from established providers are prohibiting several companies from even considering the option of exploring eMES
• Ambitious attempts to implement complete e-MES solution in single phase have also increased risk level for manufacturing companies.
• Most of the established Global players have tried to customize the General Purpose MES for Pharma Manufacturing Execution. These MES systems land up posing some of the above problems because they are not designed for Pharmaceutical Manufacturing operations with significant regulatory compliance norms. These systems arealso not architected forconfigurability and flexibility required for Pharma Manufacturing.
• Pharmaceutical Manufacturing requires even the rigidity and flexibility to be configurable.