presentation by harvindar singh on u v visible spectroscopy, CGMP

1. Submitted By
Mr. Harvindar
M. Pharm 1st sem
Submitted To
Dr. Prashant Upadhyay
Prof. IFTM University

2.  cGMP regulations are established by FDA. It contains
minimum requirements for the methods, facilities and
controls used in manufacturing, processing and of a
drug product packing .
 The regulations make sure that a product is safe for use,
and that it has the ingredients and strength it claims to
have.
 The approval process for new drug and generic drug
marketing applications includes a review of the
manufacturer's compliance with the cGMP.
 FDA can issue a warning letter or initiate other
regulatory actions against a company that fails to
comply with the regulations.

3.  GMP stands for Good manufacturing practices
that means manufacturing of product with safety and
quality to avoid contamination.
 cGMP stands for current Good manufacturing
practices, here current stands for updating technology
in cGMP.

4.  GMP Resources. Good Manufacturing Practice (GMP)
is a system for ensuring that products are consistently
produced and controlled according to quality standards.
 It is designed to minimize the risks involved in any
pharmaceutical production that cannot be eliminated
through testing the final product.

5.  FDA ensures the quality of drug products by carefully
monitoring drug manufacturers' compliance with its
Current Good Manufacturing Practice (CGMP)
regulations.
 FDA assessors and inspectors determine whether the
firm has the necessary facilities, equipment, and ability
to manufacture the drug it intends to market.Mar 30,
2018

6. Good Manufacturing Practices (GMP's) Policy. The
purpose of this policy is to ensure compliance with
current Good Manufacturing Practice (GMP) regulations
for foods. ... To ensure only safe, high quality products are
produced, employees must follow all GMP's listed:
Personal Hygiene Requirements.

7.  Materials examination and usage criteria. Records shall
be maintained for each different labeling and packaging
material indicating receipt, examination or testing, and
whether accepted o rejected.
 Labels and other labeling materials for each different
drug product, strength, dosage form, or quantity of
contents shall be stored separately with suitable
identification.
 Use of visual inspection to conduct a 100-percent
examination for correct labeling during or after
completion of finishing operations.

8.  Labeling issuance: Strict control shall be exercised over
labeling issued for use in drug product labeling
operations.
 Labeling materials issued for a batch shall be carefully
examined for identity and conformity to the labeling
specified in the master or batch production records.
 Packaging and labeling operations: Prevention of mix-
ups and cross-contamination by physical or spatial
separation from operations on other drug products
 Examination of packaging and labeling materials for
suitability and correctness before packaging operations,
and documentation of such examination in the batch
production record

9. An OTC drug product for retail sale, that is not packaged in a
tamper-resistant package or that is not properly labeled under this
section is adulterated under section 501 of the act or misbranded
under section 502 of the act, or both. Package the product in a
tamper-evident package, visible evidence to consumers that
tampering has occurred.
5. Drug product inspection.
Packaged and labeled products shall be examined during
finishing operations to provide assurance that containers and
packages in the lot have the correct label.
A representative sample of units shall be collected at the
completion of finishing operations and shall be visually
examined for correct labeling. Results of these examinations
shall be recorded in the batch production or control records.

10.  To assure that a drug product meets applicable
standards of identity, strength, quality, and purity at the
time of use, it shall bear an expiration date determined
by appropriate stability testing.
 If the drug product is to be reconstituted at the time of
dispensing, its labeling shall bear expiration
information for both the reconstituted and un-
reconstituted drug products.
 Expiration dates shall appear on labeling in accordance
with the requirements.

11. The main objective of the quality assurance is to ensure
the products are of the quality required for their intended
use-
Functions-
Adequate are made for manufacturing, supply and the use
of correct starting and packing material. Adequate control
on starting material, intermediate, and bulk products.
Process validation in accordance with established
procedures.

12.  Good Manufacturing Practice (GMP) is a system for
ensuring that products are consistently produced and
controlled according to quality standards.
 It is designed to minimize the risks involved in any
pharmaceutical production that cannot be eliminated
through testing the final product.

13.  Aseptic processing to include, as appropriate: A system
for monitoring environmental conditions (Monitoring
generally conducted under “as built”, “at rest” and
“operational or dynamic” conditions)