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.

Quality & Environmental Policy

Standard Operating Procedure for Completing Non-Conformity Report

Purpose      To ensure correct method and sequence is followed in completing a Non-conformity   Report (F-09-02)

Scope       This procedure applies to the non-conformities identified in plant products, processes and services

 Responsibilities

E NCR Originator

E Concerned Department Heads

E Quality Management Representative / QA Incharge

Procedure  E Non-Conformity Report (F-09-02) can be raised as a result of

1)      Routine Inspection / Testing

2)      Customer Complaint

3)      Internal Audit

4)      GMP Audit

5)      Self inspection

6)      Corrective / Preventive Action

A) The Person raising NCR first discuss it with his department head then follow this procedure in processing the Report.

►    Enter date of Report

►    Mark appropriate box on line 1 & 2 based on nature of non-conformity.

►    Enter document number, which is used as standard to identify the non- conformance ( SOP-08--01 etc)

►    Identify person who raised the NCR (Write name of person or customer as applicable)

►    Enter department name, product, or process for which NCR is raised.

►    Non-conformance Write brief description of non conformity with:

a)      Objective evidence

b)      Applicable procedure Para or clause reference (Para 6.2 etc)

c)      Sign and date the non-conformance statement.

B) Root Cause and Result of Investigation:-

The Department Head (where non-conformance was identified) review the NCR and determine the course of action to be followed in consultation with area Incharge. Description of cause and investigation are entered, then corrective action and its implementation is enforced.

C) Corrective Action

The concerned department head is responsible to take corrective actions for identified non conformity & forward completed NCR with support documents; report etc to Quality Management Representative,/ QA Incharge who after review assigns it the sequential No.

D) Close Out

The NCR is closed out after corrective action follow up & review by Quality Assurance Manager / Quality Management Representative / Internal Auditor as applicable.

E) Quality Management Representative / QA Incharge maintains log of all NCRs & send copies of completed NCR to the concerned department. Quality Management Representative present status of non-conformance to management in Management Reviews as per Quality Management System.

F) Each department head should maintain documented record of non-conformances in their department.

Related Documents & Forms

Control of Non Conformity Corrective & Preventive Action            E   (QSP-09)

Product Recall                                                                                    E   (SOP-09-PRL)

Internal Quality Audits                                                                       E   (QSP-10)

Non-Conformity Report                                                                     E   (F-09-02)

Customer Complaint Log Marketing                                                  E   (F-09-01)

Log of NCRs (Product, Process Service)                                           E   (F-09-05)

SOP For Measuring / Monitoring of Noise Level

Scope:-

This procedure provides the guideline for measuring /monitoring of Noise Level at

Purpose:-

To maintain safe noise levels in the plant premises and avoid hearing impairment due               to Excessive noise level.

Responsibility:-

                       

                 Maintenance Incharge.

                 QA Incharge

                 QA Officer

Procedure:-

Excess noise levels (78 dBA) are harmful for the health of human ears and can adversely affect the worker’s performance if exposed to high noise levels over extended period.

To ensure good health & maintain tolerable noise level, noise levels in different areas of Plant are monitored by QA department. Noise level meter with the range of noise detection of 30-130dBA is utilized for the monitoring.

 Incharge QA prepare a plan for noise level monitoring within Plant premises as part of HSE plan. The safe noise level is established for each working area specially production, packing and store areas where noise level due to machine operations could be high. The criteria for monitoring frequency is as follows:

a)      Monitoring noise level at the time of machine/equipment installation.

b)      Monitoring all working areas every quarterly and maintain records.

c)      Monitoring an area based on complaints of excessive noise from the workers/supervisor.

            Maintenance &   QA Incharge operate the meter for monitoring noise levels.

            Operation of Noise Meter:

           Noise level meter has measuring range 30-130dBA frequency range 31.5 Hz

           to 8 KHz and resolution of 0.1dBA. It is a hand held unit with a sensitive microphone,                           extension cord and operated with 9 volt battery

1)        Install the battery by opening battery cover on the unit.

2)        Calibrate the meter before operation.

3)        Ensure meter microphone is dry and protect it from area wind effects by using windscreen around the microphone

1)        Use the extension cable of the microphone. When monitor the noise level to avoid unexpected Noise reflection.

2)        Turn the power switch “ON” on the unit and select the desired “Response time” & “Weighting”. Set response time to “Fast” setting for noise, which consists of short bursts, or for catching peak Sound level. To measure average level use the setting “Slow”.

3)        Select the weighting “A” for general noise level and weighting “C” for measuring noise level of acoustic sound.

4)        Hold the instrument in hand or fix on tripod, pointing the microphone at the noise source. The noise pressure level will be displayed on the meter.

5)        When measuring noise level of different locations in an area use “Max/Min” mode to determine maximum and minimum noise levels of the area.

6)        Press “Max/Min” button once to measure value of maximum noise level. Pressing again will give minimum noise level. At the end press the button third time to exit measuring mode (Max. or Min. symbol will disappear from the screen.)

7)        Turn off the instrument after measurements and record the observations on Noise monitoring record form.

8)        Do not operate or store instrument at high temperature and high humidity environment.

9)        Avoid microphone exposure to excessive vibration.

10)    Remove  battery when instrument is not in use.

11)    Analyze measurement data and discuss in management meeting to determine the corrective & preventive measures and controls for high noise levels.

Standard Operating Procedure for Monitoring of Operational Parameters of Sterile Area

1.         Purpose:-

To maintain environmental conditions within prescribed limit.

To prevent the microbial proliferation.

To Safeguard the product during filling operation

To provide the comfort environment to the operators during filling.

2.         Scope:-

This procedure is followed while maintaining the environmental condition.

3.         Responsibility:-

                        1          HVAC operator

                        2          Microbiologist

                        3.         Incharge Pharmacist

                        4          Sterile Area Operator

4.         Procedure:-

The operational parameters & their limits are as under

STANDARD OPERATING PROCEDURE FOR SPECIFIC TRAINING OF PERSONNEL’S (QAD)

1.       Purpose:

1.1.  The purpose of this SOP is to describe the procedure of specific training of QA personnel.

2.       Scope:

             This SOP is applicable to Quality Assurance Department.

3.       Responsibility:

             Quality Assurance Manager

4.       Procedure:

      4.1. On joining of new personnel to Quality Assurance Department, QA Manager issues job description (JD) to the personnel.

4.2. Specific training program to the new employees (Quality Assurance Officer, Quality Assurance Inspector/ Quality Assurance Assistant) of quality assurance department must covers the following aspects

S/N	Training Topic
01.	Introduction to Quality Assurance.
02.	Awareness on cGMP.
03.	Introduction to Quality Audit.
04.	Market Complaints and Product Recalls.
05.	Self-study of Quality Assurance SOPs.

     4.3. Specific training must be completed within two weeks of the joining of new personnel’s.

     4.4. Assessment of the new personnel must be done after the completion of the training program.

     4.5. Record of such trainings should be kept with the Quality Assurance Department.

    4.6. Besides the specific training of the new employee, QA new employee will also receive continuous trainings as per SOP for the Training of Personnel’s (Ref. # QA/T/01).

5.       List of Recipients:

5.1. Quality Assurance Department.

Flow Chart of Raw Material Store