Manufacturing operation and control

1. TOPIC – Manufacturing operation
and control.
UNDER THE GUIDANCE OF
PROF. V.R.SINHA
UNIVERSITY INSTITUTE OF PHARMACEUTICAL
SCIENCES
PANJAB UNIVERSITY, CHANDIGARH

2. • Good Manufacturing Practice, which are currently acceptable should be
followed during carrying out all manufacturing operation and their control.
Four
Keys
Identify
Strength
Safety
Purity
Introduction

3. Processing and intermediate and
bulk products
Starting from the receipt of raw materials till these materials are converted into bulk
goods ready for packaging into their primary and then finished packs, certain points
are required to be kept in mind so that the identity, strength, safety and purity of
product is maintained. Following are some of these paints:
• Before starting any processing, the materials received from the stores should be
checked for the identity and quantity.This verification can be done against the
labels on their containers and by actually weighing or measuring the quantity of
materials.
• Process area and equipment must be clean and no traces of previous product
should be there.
• Environmental conditions must meet the processing requirements
e.g. temperature, relative humidity, pressure gradient, class of air, lighting etc ,
such observations should be recorded in BPCR and other relevant registers etc.

4. CONTINUE….
• Processing and intermediate and bulk products . All primary containers used
for filling of finished products should be clean to the acceptable level of
cleanliness. Bulk containers used for storage of in-process materials should
also be thoroughly cleaned before use.
• Yield of materials at all critical stages of operations should be checked e.g.
granulation, compression, filling operations of capsules, liquid bottles etc.
and compared against theoretical yields expected, any abnormal deviations
must be investigated and corrective actions taken.

5. CONTIUNE….
• All measuring, weighing, recording and controlling equipment and
instrument should be calibrated regularly so that they always remain in a
state of calibration. Records of such calibrations should be maintained.
• Repairs and maintenance operations should not present any hazard to the
quality of the products.
• All IPQC checks should be carried out is to be recorded and investigated.
• Access to production areas should be restricted only to authorized persons.

6. • Pharmaceutical ProcessValidation, Chapter 20 by Robert A Nash & Alfred HWachter
• Pharmaceutical Quality Assurance, Manohar A Patidar, Nirali Prakashan.
• International Journal of Industrial Pharmacy and Bio Sciences 1(1): May-June 2014
• 21 Code of Federal Regulations Parts 210 and 211, 211.215
• Received: 09-05-2012; Revised; Accepted: 06-05-2014 IN PROCESS QUALITY
CONTROL: A REVIEW PranshuTangri*, Praveen Mamgain, Shaffi, Abhay MLVerma,
Lakshmayya GRD (PG) IMT, Dept. of Pharmacy, Dehrdaun, Uttarakhand, India
• https://www.pharmaguideline.com/2011/09/mix-up-and-cross-contamination-
in.html
• https://www.pharmatutor.org/articles/quality-management-waste-scrap-disposal
Reference