procedure for Quality Management
1.0 OBJECTIVE:
1.1 To lay down a procedure for Quality Management.
2.0 SCOPE:
2.1 This procedure is applicable for formulation plants of ……
3.0 RESPONSIBILITY:
3.1 Head Quality Assurance shall be responsible for compliance of this SOP
3.2 Heads of Production, QC, Warehouse, Engineering & HR etc. shall be responsible for implementation and compliance of the SOP.
4.0 ACCOUNTABILITY:
4.1 Head QA
5.0 PROCEDURE:
5.1 Quality Management Review shall be done by Quality Council.
5.2 Quality Council team (refer Annexure-1) shall be constituted by Head-QA for Quality Management Review.
5.3 Quality Council team consists of Head or his/her designee from each department of the plant.
5.4 Quality Management shall provide the framework for implementing the quality procedures, check the suitability, adequacy and effectiveness of the quality system, continuous improvement and risk management.
5.5 Following points shall be discussed in Quality Management meeting:
1.0 Batch Production & Control Records and other Production records.
2.0 NCR, Deviations, CAPA, Incident and change control.
3.0 System failures in the manufacturing process.
4.0 SOPs, STPs and Specifications etc
5.0 Technology transfer
6.0 Market complaints and Product recalls
7.0 Self Inspection/Quality system
8.0 Plan Vs Actual
9.0 Availability of materials as per the plan
10.0 Capacity Utilization
11.0 Cost effectiveness
12.0 Manpower Utilization
13.0 Preventive maintenance of critical equipments
14.0 New initiatives for continuous improvement
5.6 Operation and Quality Review meetings shall be organized at least once in every quarter of a calendar year.
5.7 Meeting report shall be concluded (refer Annexure-2) with possible solutions for all issues raised in meeting.
6.0 ABBREVIATION:
| S. No. | Abbreviations used | Full form of Abbreviation used |
| 1. | QA | Quality Assurance |
| 2. | SOP | Standard Operating Procedure |
| 3. | STP | Standard Test Procedure |
| 4. | CAPA | Corrective and Preventive Action |
| 5. | QC | Quality Control |
7.0 ATTACHMENTS (ANNEXES) :
Annex –I : Quality Council team
Annex –II : Quality Management Meeting Report
8.0 REFERENCE :
| S. No. | Reference Title |
| 1.0 | As per WHO guideline |
Annex –I : Quality Council team
Annex –II : Quality Management Meeting Report
Online Rejection in parenteral
Receipt of Batch from Production to Packing Department
sop for for Spillage Handling in parenteral area
sop for calibration of vessels with dipstick
sop for Cleaning of Bins and Containers
cip of mixing vessel and holding vessel
sop for Cleaning of Ampoule Filling and Sealing Machine
sop for Fogging in Sterile and Non Sterile Area
sop for for Filtration of Bulk Solution
sop for fumigation in production area
sop for post cleaning after media fill
sop for cip of mixing vessel mixing mobile vessel and holding vessel
sop for De-Bagging of Three Piece Vial Dropper Caps
sop for calibration and verification of check weigher
sop for Batch number and Manufacturing and Expiry Date Coding System
standard operating procedure machine history file
sop for operation and cleaning of Hand coder
sop for Cleaning and Handling and Silicone Tubes
sop on operation and cleaning of coating pan
sop for Operation of cleaning of pipe lines
sop for operation of capsule loading machine semi automatic
sop for Machine operation capsule inspection and polishing machine
Sop batch demarcation and batch coding
sop for monitoring of reprocessing of products
sop for in-process control on liquids orals
sop for in process controls on tablets capsules packaging line
sop for Issuance retrieval and destruction of BMR and analytical records
sop for in process controls during granulation compression coating inspection
sop for Cleaning of Blister packing machine
sop for for charge hand over between the shifts
Performance requalification report of visual inspectors
sop for Cleaning and operation of ROPP caps inspection table
sop for usage and destruction of filter pad and cartridge filter
sop for cleaning and storage of transfer pipe
sop for Cleaning and operation of labeling machine
Cleaning and operation of the mono block filling and sealing machine
sop for Cleaning and operation of empty bottle inspection table
sop for Cleaning and operation of filter press
sop for cleaning and operation of liquid transfer pump and line
sop for cleaning and operation of storage vessels
sop for cleaning and operation of sugar syrup manufacturing vessel
sop for cleaning issuance and retrieval of accessories and change parts
sop for Cleaning and operation of visual inspection conveyor belt