CSF- Defects

Consequences of Defects
DEFECTS
1. Market complaints- DEFECTS
• Implies customer is not satisfied
• Indicates dissatisfaction regarding the clinical indication, quality BEFORE AFTER
or packaging which is lodged verbally or in written forma BEFORE
LAUNCH AFTER
LAUNCH
LAUNCH LAUNCH
2. Drug Recall-
• Due to lack of integrity in quality and safety of manufactured drug
Drug Recall Classification

Methods used to minimize defects- Product may cause serious

Class -1
• Check Sheets health problem or death
• Cause-effect Diagram
Product may cause a
• Pareto Chart Class-2
• Process-Flow Chart
temporary health problem
Class-3
Product violates labelling or
manufacturing laws
CSF-Supplier Relation Management
Supplier relationship management (SRM) is the systematic approach of assessing suppliers’ contributions and
influence on success, determining tactics to maximize suppliers’ performance. The typical goal of SRM is to
streamline and improve processes between a buyer and its suppliers
Supplier relationship management is important because, over time, a long-term relationship between your
company and its suppliers allows for the free-flow of feedback and ideas. Over time, this will create a more
streamlined, effective supply chain that will have a positive impact on costs and customer service.
Benefits of SRM-

SRM allows for making quick and informed

decisions
SRM leads to ongoing process improvement
SRM leads to reduced costs.

SRM boosts supplier-led innovation

Technological Advancements Supporting TQM
Diffuse Reluctance Measurement-
• It is an excellent sampling tool for powdered or crystalline materials in the mid-IR and NIR (near-infra red)
spectral ranges
• It is used for monitor an ongoing process or ongoing reaction
CIP & WIP-
• CIP is also called clean in place. It involves cleaning of equipment with minimum involvement of the
operator. WIP is also known as wash in place
• Benefits of CIP & WIP:
-Reduction of cleaning time
-Improved health and safety
Sensors Technology in Packaging-
• Sensors based technology in packaging of pharmaceuticals has opened a new vista in online and in-process
monitoring of packaging process.
• Some of the recently used sensors are
-Ultrasonic sensor for filling level measurement
-Holographic Technique