Standard Operating Procedure For Product Data Analysis

Purpose:-

To analyse product related data for conformance to specifications, determine trends & to take appropriate actions for improvement.

Scope:-

Product & process quality evaluation at Plant by using suitable statistical techniques.

 Responsibility:-

ù Plant Manager

ù Quality Control Manager

ù Quality Assurance Manager

ù QC Officer

ù QA Officer

Procedure:-

                        The following statistical techniques / tools are being used in the plant.

A)                Sampling Plan for Incoming Materials & Product

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.

 B)                Trend Analysis

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.

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.

 B)                Variance Analysis:

This statistical technique is applied for the data analysis in

a)                  Liquid Injectable Volume data in QC Lab.

b)                  Powder Injectable drug weight data in QC Lab

c)                  Weight Variation data of OSD (Tablets & Capsules) forms in QC Lab.

d)                 Liquid Syrup Volume data in QC Lab

e)                  Analytical method validation in QC Lab.

f)                   Process Validation in Production

Standard deviations calculated to establish consistency of the relevant process / method.