Statistical process control (SPC) uses statistical methods to monitor manufacturing processes and ensure they operate efficiently to produce products that meet specifications. Key SPC tools include run charts, control charts, and design of experiments. Quality measurements are central to quality control and provide feedback on processes. For pharmaceutical manufacturing, in-process checks are important and include checking drug content uniformity, particle size, and filling amounts at different stages of production for various dosage forms like parenterals, solids, and semisolids. Control charts are essential tools to monitor processes and identify factors affecting performance.

1. STATISTICAL PROCESS CONTROL-QUALITY MEASUREMENTS
IN MANUFACTURING.
DEPARTMENT OF PHARMACEUTICAL QUALITY ASSURANCE
SUBJECT - QUALITY MANAGEMENT SYSTEM [QMS]
Presented by- Under guidance of –
Karishma P. Fuse Dr.A.G.Pise
M.pharm 1ST Year M.pharm, Ph.D.
DADASAHEB BALPANDE COLLEGE OF PHARMACY ,BESA , NAGPUR 440037
YEAR 2020-2021

2. STATISTICAL PROCESS CONTROL
SPC is a method of quality control which employees the statistical method to monitor and control a process. This helps to ensure the
process operates , efficiently, producing more specification –conforming product with less waste (rework or scrap).
SPC can applied to any process where the “conforming Product” (product meeting specification) output can be measured . Key tools
used in SPC include run charts ,control charts ,focus on continuous improvement ,and the design of the experiments.
Statistical process control as the application of statistical method to the measurements and analysis of variation in a process.
The techniques applies to both in-process parameter and end of process parameter. A process is a collection of activities that converts
inputs into outputs or results.
More specifically a process is a unique combination of machine, tools, methods, materials and peoples that attain an output in goods,
software or services.
Important for improving quality. Identifies any decline in the quality initial stages of production and taking immediate corrective steps
instead of identifying defectives after the damage has been done.
One of the method used in identifying defects in “SAMPLING”.
Sampling always shows defects as well as 100% inspection.

4. QUALITY MEASUREMENTS IN MANUFACTURING
• Quality measurements is central to the process of quality control – “what gets
measured ,gets done”.
• Measurements is basic for all three operational quality process and for strategic
management.
1. Quality control management- Provides feedback and early warnings of problems
.
2. Operational quality planning measurements -- quantifies customers needs and
product and process capabilities .
3. Quality improvements measurements – can motivate people, prioritize
improvements opportunities and help in diagnosing causes.

9. QUALITY MEASUREMENTS IN MANUFACTURING OF DIFFERENT TYPES OF FORMULATION
The in-process checking
during manufacturing plays an
important role in the auditing
of the quality of the product at
various stages of production
duties of the control inspector
consisting of checking,
enforcing and reviewing
procedures and suggesting
the change for upgrading the
procedures when necessary.
The aim of the process quality
control system is to monitor all
the features of the product
that may affect its quality and
to prevent error during
processing.

10. PROCESS CONTROLS INVOLVED IN THE MANUFACTURING PROCESS OF PARENTERAL
Step 1 – Checking
the bulk solution .
Step 2 - checking
the filled volume
/sterile powder
weight .
Step 3 – Physical
examination
Step 4 – sterility
indicator

11. PROCESS CONTROL INVOLVED IN MANUFACTURING PROCESS OF SOLID DOSAGE FORM
Step 1 –
Determination of
solid content
Step 2 – Checking of
weight variation.
Step 3 –
Determination of
post formulation test.

12. PROCESS CONTROL INVOLVED IN THE MANUFACTURING OF THE SEMISOLID DOSAGE FORMS.
Step 1 –
Checking the
drug content
uniformity.
Step 2 –
Determination
of particle size.
Step 3 –
Checking the
appearance
Step 4 – Testing
for filling and
leakage

13. SIGNIFICANCE
• Control chart are essential tool of continuous quality control.
• Control charts monitor processes to show how the process is performing
and how the process and capabilities are affected by changes to the
process.
• Significant quality improvements.
• Identification of special or assignable causes for factors that impede peak
performance .

14. REFERENCES
• https://www.slideshare.net/mobile/AnkitaGorhe/statistical-process-control-
125275380
• https://www.slideserve.com/maxime/statistical-process-control-and-quality-
management
• https://www.slideshare.net/mobile/XenChisti/statstical-process-control
• https://www.engusa.com/en/solution/manufacturing-quality-control-and-spc
• www.Wikipedia.com
• www.google.com