This document outlines the responsibilities and functions of a quality control department in a pharmaceutical company. It discusses that quality control ensures the identity and purity of pharmaceutical products through procedures like sampling, testing, and record keeping. The main responsibilities of quality control are ensuring safety, efficacy, quality, and compliance of products. Quality control operations include sampling, testing, validating methods, instrument maintenance, in-process quality control, and batch inspection. The quality control department needs adequate facilities, trained personnel, approved procedures and appropriate environmental conditions to perform these operations successfully.

1. Name : Nikita U. Kakad
Roll No. 09 (QA)
Class : M. Pharm Sem 2
SANDIP INSTITUTE OF PHARMACEUTICAL SCIENCES

2.  Introduction
 Objectives
 Responsibilities
 Functions
 Components
 Operations
 Design of QC lab
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3.  The term quality control refers to the sum of all procedures undertaken to
ensure the identity purity of a particular pharmaceutical product.
 Quality control, or QC for short, is a process by which entities review the
quality of all factors involved in production.
 ISO 9000 defines quality control as "A part of quality management
focused on fulfilling quality requirements".
 Quality control is a measure of precision, or how well the measurement
system reproduces the same result over time and under varying operating
conditions.
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4.  QC is a part of GMP concern with sampling , specifications & testing &
with the organization , documentation & release procedures which
ensures that the necessary & relevant tests are actually carried out & the
materials are neither release for use nor products are used for sale &
supply until their quality has been satisfactory.
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6.  Establishment of quality standard.
 Locating quality deviations.
 Evaluating methods & processing's of production.
 Preventing the defects in product manufacturing.
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7.  The four main responsibilities of quality control in
pharmaceutical industry include :
1. Safety
2. Efficacy
3. Quality
4. Compliance
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8. 1. Determining the standards
2. Keeping the records
3. Determining the sampling limits
4. Development of better quality devices
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10.  Adequate facilities
 Trained personnel
 Approved procedures
 Appropriate environmental conditions
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13.  Sampling
 Testing
 Record management
 Validation of analytical methods & procedures
 Instrument maintenance
 IPQC
 Batch inspection
 Retained samples
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14.  QC should have sop for sampling of RM/PM/Int. & finished
products.
 Approved methods
 Well trained personnel
 Appropriate sampling tools & records maintained
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15.  Testing is the main activities of QC department in any
manufacturing units.
 Testing of materials involves testing of following materials :
1. API
2. Packaging materials
3. In process materials
4. Finished bulk & packed products
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16.  Records must be made demonstrating that all the required
sampling , inspecting , testing procedures have actually been
carried out & that any deviation have been recorded &
investigated.
 Recording is basic part of any pharmaceutical activity &
therefore al the records are maintained when each & every
activity is carried out.
 This helps in tracing history of a batch produced , this may be
required in future if any investigation is to be made.
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17.  All the methods used by QC say for sampling , testing & other
activities must be validated.
 Analytical testing procedures including stability testing
methods must be validated to demonstrate their reliability.
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18.  All the instruments which are used in QC labs should be
regularly maintained.
 Ensure that instruments are serviced regularly by specialized
service engineer & that this maintenance is documented.
 Every equipment has a log book for records.
 All equipments are calibrated at specified intervals.
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19.  They are used to detect variations from tolerance limits of the
products so that corrective actions can be taken.
 IPQC ensures the batch uniformity & integrity of the drug
product.
 It is the activity performed between QA & QC
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23.  It consists of change room for men & women , facility for
drinking water outside the department.
 Store rooms for storage for glass wares , delicate items ,
chemicals & microbiological media etc.
 There is wet chemistry lab for chemical testing.
 QA documentation room for preparation of BPCR , control
reports etc.
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24.  QC department should have minimum following areas :
1. Separate change rooms for men (10*7m) & women (8*7m).
2. Office for QA & QC (3*3m).
3. Store rooms for different items (4*4m).
4. Conference rooms for 8 people (6*4m) & 4 people (4*4m) sitting
arrangement.
5. Sample rooms (4*3m).
6. Document room (4.8*3m).
7. Stability chamber (6*5m).
8. Instrument laboratories (6*5m).
9. Wet chemistry lab (6*5m).
10. Microbial assay room (6*5m).
11. Stability testing room (6.4*4.7m)
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