IN PROCESS QUALITY CONTROL(IPQC) ON VARIOUS DOSAGE FORMS
GUIDE BY : PRESENT BY:
MR.Ashok mahajan Anuj patel
DEPARTMENT OF QUALITY ASSURANCE
A.P.M.C. PHARMACY COLLEGE
• USFDA cGMP Guidelines
• IPQC for Parenteral products
• IPQC for Solid dosage forms
• IPQC for Semisolid dosage forms
• Completion stage
• Records and Reports
In process quality control (IPQC) is a planned
system to identify the materials, equipments,
processes, and operators; to enforce the flow of
manufacturing and packaging operations according to
the established rules and practices; to minimize
human error or to detect the error if and when it does
occur; and to pinpoint the responsibility to the
personnel involved in each unit operation of the entire
In general, in process control procedures are
usually rapid and simple tests or inspection that are
performed when the manufacturing of the product
batch is in process.
• The primary objective of an IPQC system is to
monitor all the features of a product that may affect
its quality and to prevent errors during processing.
• The in-process checking during manufacturing plays
an important role in the auditing of the quality of
the product at various stages of production
• They are used to detect variations from the
tolerance limits of the product so that prompt and
corrective actions can be taken.
USFDA cGMP guidelines
• To assure batch uniformity and integrity of
drug products, written procedures shall be
established and followed that describe the in-
process controls, and tests, or examinations to
be conducted on appropriate samples of in-
process materials of each batch.
• Such control procedure shall be established to
monitor the output and to validate the
performance of those manufacturing processes
that may be responsible for causing variability
in the characteristics of in-process material and
the drug product.
• Valid in-process specification for such
characteristics shall be consistent with drug
product final specifications.
• Examination and testing of samples shall
assure that the drug product and in-process
material conforms to specification.
• In-process materials shall be tested for
identity, strength, quality, and purity as
appropriate, and approved or rejected by the
quality control unit, during the production
process, e.g., at commencement or completion
of significant phases or after storage for long
IPQC for Parenteral products
• Checking the bulk solution, before filling, for drug
contents, pH, color, clarity and completeness of solution
• Checking the filled volume of liquid or the filled
weight of sterile powders for injection in the final
containers at predetermined intervals during filling
• Testing for leakage of flame-sealed ampoules
• Subjecting the products to physical examination
(visually or mechanically) for appearance, clarity and
• Examining the sterility indicator placed in various areas
of the sterilizer for each sterilization operation
• Submitting the product for sterility testing or other
predetermined biologic test to establish the safety and
other parameters of the product.
IPQC for solid dosage forms(Tablets
• Determining the drug content of the formulation
• Checking the weight variation for tablets and
capsules at predetermined intervals during
• Checking the disintegration and/or dissolution
time, hardness and friability of the tablets, at least
during the beginning, middle and end of the
production or at prescribed intervals during
• Testing soluble tablets for compliance with solution time
• Examining products by line inspection or other equally
suitable means and removing the defective units prior to
IPQC for semisolid dosage forms
• Checking for uniformity and homogeneity of drug
content prior to the filling operation.
• Determining the particle size of the preparation
• Checking the appearance, viscosity, specific
gravity, sediment volume and other physical
parameters at prescribed intervals.
• Testing for filling weight during the filling operation
• Testing for leakage on the finished jars or tubes.
• Actual yield are checked against theoretical value and
the representative samples are withdrawn for laboratory
testing by the control inspector according to the
predetermined sampling plan.
• The operator actively performing the process, their
supervisors, and the control inspector must all verify
that the entire operation was accomplished in the
• Occasionally, materials in bulk storage are sampled at
random and are examined to determine that no
detectable change has taken place, and that the batch is
satisfactory for final packaging.
Records and Reports
• The batch production records and other needed
documents are then delivered to the quality control office
together with the withdrawn samples of the products.
• These records and test results are reviewed for
conformance to specification and cGMP. The bulk
finished products are held in quarantine until they are
released for packaging by quality control personnel.
• Leon Lachman, H.A.Lieberman, J.L.Kanig, “The
Theory and Practice of Industrial
Pharmacy”;Varghese Publishing House; 804
• Sidney H. Willig; “Good Manufacturing Practices for
Pharmaceuticals” Fifth edition; Marcel Dekker