Contamination is the undesired introduction of impurities

(of a chemical or microbiological nature) or of foreign

matter, into or onto a starting material or intermediate or
API during:
production
sampling
packaging or repackaging
storage or transport.
Cross-contamination is the contamination of a
starting material, intermediate or finished
product with another starting material or
product.
 Manufacturers must have processes in place, to not
only avoid contamination scenarios but also
provide documented evidence that contamination has
not occurred.
The reasons for contamination and cross-
contamination can vary and be caused by technical
or deficiencies within the organization.
From where does cross-contamination
originate?
1. Poorly designed air handling systems and
dust extraction systems
2. Poorly operated and maintained air handling
systems and dust extraction systems
3. Inadequate procedures for personnel and
equipment
4. Insufficiently cleaned equipment
 Good documentation constitutes an essential part of
the quality assurance system and is key to operating
in compliance with GMP requirements.
Documentation may exist in a variety of forms,
including paper-based, electronic or photographic
media
 The main objective of the system of
documentation utilized must be to establish,
control, monitor and record all activities
which directly or indirectly impact on all
aspects of the quality of medicinal products
 There are two primary types of documentation
used to manage and record GMP compliance:
A. instructions (directions, requirements)
B. records/reports.
1) Specifications
Describe in detail the requirements with which the products or
materials used or obtained during manufacture have to conform.
They serve as a basis for quality evaluation.

2) Manufacturing Formulae ,,Processing, Packaging

and Testing Instructions:
Provide detail all the starting materials, equipment and
computerized systems (if any) to be used and specify all
processing, packaging, sampling and testing instructions.
3) Procedures
(Otherwise known as Standard Operating Procedures, or
SOPs), give directions for performing certain operations.
4) Protocols:
Give instructions for performing and recording certain
discreet operations.
5) Technical Agreements
Are agreed between contract givers and acceptors for
outsourced activities .
 A Batch Processing Record should be kept for each batch
processed. It should be based on the relevant parts of the currently
approved Manufacturing Formula and Processing Instructions.

It should contain the following information:

1. The name and batch number of the product
2. The date and time of commencement of intermediate stages and
of completion of production
3. Identification of the operator(s)
4. The batch number and/or analytical control number as well as the
quantities of each starting material
5. Any relevant processing operation and major equipment used
6. Note on any problems or unusual events including details
7. A record of the in-process controls and the initials of the person(s)
carrying them out and the result obtained
8. The product yield obtained at different stages of manufacture
 Storage area should be of sufficient capacity to allow orderly
storage of the various categories of materials and products with
proper separation and segregation :Starting and packaging
materials ,intermediates, bulk and finished products , product in
quarantine ,and released ,rejected ,returned or recalled products.
Storage areas should be designed or adapted to ensure good
storage condition .
In particular , should be clean and dry and maintained within
acceptable temperature limits.
 Validation is a documented program which
provides a high degree of assurance that a
specific process will consistently produce a
product meeting its predetermined
specifications and quality attributes.
1. Plan: Qualitative or quantitative or both; what
kind of information have; which technique is
suitable etc.
2. Sampling: Accuracy depends on proper
sampling, characteristic of sample is very
important, required good representative
sample (from top, middle and bottom and
mix up and take average sample).
3. Sample preparation: depends on analytical
techniques.
4. Analytical measurement:
5. Data Analysis: Whether the data make sense
or not.
 To prove what we claim is true
To increase the value of test results
To justify customers trust
Accuracy is the measure of exactness of an
analytical method, or the closeness of agreement
between the measured value and the value that is
accepted as a conventional true value or an
accepted reference value.
The determination of Accuracy usually requires a an
accepted method to which a new method can be
compared
-
 The precision of an analytical procedure is
usually expressed as the variance,
standard deviation or coefficient of
variation of a series of measurements.
 All types of analytical methods require
calibration for quantitation. Calibration is a
process that relates the measured analytical
signal to the concentration of analyte. We
cant just run a sample and know the
relationship between signal and
concentration without calibrating the
response
The three most common calibration
methods are:
Calibration curve
Standard addition method
Internal standard method
 Recovered materials are those materials that have been
diverted or removed from the solid waste stream for
sale, reuse or recycling, whether or not they require
subsequent separation and processing .
 It gives the company an opportunity to improve the
quality of the product
It is helpful to maintain cGMP
It maintains committed relationship between the
customer and company.
It is the regulatory obligation.
1. OBJECTIVE: To lay out the procedure for investigation
and reporting the market complaints.
2. RESPONSIBILITY: The quality assurance manager
along with manager of the complaint related
department.
3. PROCEDURE: Complaints shall be classified in
following categories to facilitate investigation:
I. Product quality complaints (non therapeutic).
II. Packaging complaints (shortages and packaging
error).
III. Medical complaints (therapeutic problems).
 CLASS I RECALLS is a situation in which there is a
reasonable probability that the use of, or exposure to, a
violative product will cause serious adverse health
consequences or death.
CLASS II RECALLS is a situation in which use of, or
exposure to, a violative product may cause temporary or
medically reversible adverse health consequences or
where the probability of serious adverse health
consequences is remote.
CLASS III RECALLS is a situation in which use of, or
exposure to, a violative product is not likely to cause
adverse health consequences.
Thank you