Product Data Analysis SOP



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




No comments:

Post a Comment