Product Data Analysis SOP
1.0
PURPOSE:
|
1.1. To analyze
product related data for conformance to specifications, determine trends &
to take appropriate actions for improvement.
2.0 SCOPE:
|
2.1. Product &
process quality evaluation at Plant by using suitable statistical
techniques.
3.0 RESPONSIBILITY:
|
3.1. Quality Control Manager.
3.2. Quality Assurance Manager.
3.3. Quality Assurance Officer.
4.0 PROCEDURE:
|
4.1. The following statistical techniques /
tools are being used in the plant.
4.1.1. Sampling Plan for Incoming Materials &
Products:
4.1.1.1. For the sampling of incoming goods
and produced batches American
military standard MIL-STD 105 – E is being used to take the representative samples for inspection / testing of raw
materials, packaging
components and finished products. Acceptance levels are defined on the basis of these plans and reports are
generated for each sample and analysis
4.1.2. Trend Analysis:
4.1.2.1. In process Inspection Data:
Physical
parameters of liquid injections, Liquid syrup, Tablets, Capsules and dry powder
injections are checked during the operation at predefined frequencies. Results
are plotted on pre-printed trend charts (range charts) are provided with upper
and lower allowable limits.
Trends
are reviewed regularly during the process by production and IPC staff and are
finally reviewed by QC Department before final release.
4.1.2.2. Finished Products (Active Potency
data analysis by Line Graph)
Results
of active ingredient’s assay are plotted for each batch on graph sheet to
analyze the trend of batch wise product quality.
These
plotting are reviewed in GMP committee and quality council meetings. The
observations are discussed & appropriate corrective and preventive actions
are identified for improvement.
4.1.3. Variance Analysis:
4.1.3.1. This statistical technique is
applied for the data analysis in.
• Weight Variation data of OSD (Tablets
& Capsules) forms in QC Lab.
• Liquid Syrup Volume data in QC Lab
• Analytical method validation in QC
Lab.
• Process Validation in Production.
4.1.3.2. Standard deviations calculated to
establish consistency of the relevant
process / method
5.0
REVIEW FREQUENCY:
|
SOP
will be reviewed at least annually.
6.0 RISK ANALYSIS:
|
EVIDENCES OF RECORDS
& REFERENCES
|
Log Books of all Departments
BMRs
|
||
FORMAL KPIs (Key
Performance Indicators)
|
Retrieval and access is
easy and possible as and when required.
|
||
GENERAL RISKS
|
CONTROL MEASURES
|
CUSTODIAN
|
|
Risks
|
Impact
|
||
Data analysis not done
through proper channel/ process.
|
Problem not identified if
any problem occurs in any Batch.
|
Follow every process of
Data Analysis and through proper channel.
|
QA Officer
QA Manager
Store Incharge
|