Follow
OBJECTIVE
To provide the guidelines for compilation of data for process parameters, assay values for actives to establish that Process performs according to design and is under control. Trend analysis data can be used to apply reduced testing in non-regulatory specifications after having established the consistency.
SCOPE
This procedure is applicable to the various process parameters involved in manufacturing of tablets, capsules, metered dose inhalers at (Company Name).
RESPONSIBILITY
1. Manager, Production shall be responsible for compilation the data on various process parameters.
2. QA Officer shall be responsible to analyze and conclude the results obtained from Batch Manufacturing Records (BMRs) & Batch Packing Records (BPRs).
3. Manager, QC shall be responsible for compilation of analytical data, analyze and conclude from the results obtained.
4. Manager, QA shall be responsible for verification the compiled data and conclusion drawn and suggest the changes in the process.
5. Head of Quality or his/her designee shall be responsible to approve / Reject the suggestions.
PROCEDURE
** Trend is defined as a general direction in which something is developing or changing. It is the practice of collecting information and attempting to spot a pattern in the information.
** Various process parameters which shall be recorded for establishing the trend and / or verification of designed parameters are as under.
** Tablets: Moisture Content, Assay values for finished products, DT, Dissolution, Average weight and Yield.
** Capsules: Assay values for finished products, DT, Dissolution, Average weight and Yield.
** Metered Dose Inhalers: Product concentrate, number of deliveries per inhaler, Leakage rate, Water content, Deposition of emitted dose, Weight average by dose/ mean weight per metered dose, Assay of active per actuation and Yield.
** Raw Material: Assay, Water content / LOD, pH and Bulk Density.
** Primary Packaging Material: Grammage, Thickness, Width, Canister Body diameter, Brimful volume, Canister depth, Canister inside diameter, Canister minimum parallel, Canister neck depth, Neck diameter, Neck thickness, Overall length, Rim diameter, Rim thickness, Wall thickness, Canister weight, Ferrule long skirt length of valve,
Main valve outside diameter, Ferrule top to step height, Length of core extension, Core extension diameter, Total height, Nominal stroke.
** Water System: pH value of Potable and Purified water, online conductivity value of purified water, Online TOC value of purified water.
** Minimum 3 batches in a year or all the batches, less than 3 batches/lots in a year shall not be considered for trend analysis.
** Any physical parameter which appears to be deviating more, frequency for IPQA check for such parameter can be increased.
** Based on the observed trend analysis, if any change is to be incorporated, it shall be executed as per Change Control procedure
