Standard Operating Procedure of Product Data Analysis in Pharmaceuticals is describe in this post.
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1. Purpose:
1.1. To analyze product related data for conformance to specifications, determine trends & to take appropriate actions for improvement.
2. Scope:
2.1. Product & process quality evaluation at Plant by using suitable statistical techniques.
3. Responsibilities:
3.1. Quality Control Manager.
3.2. Quality Assurance Manager.
3.3. Quality Assurance Officer.
4. 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.
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