Documents to be produced for Inspection
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Water System
Whether the unit has validate system for treatment of water
drawn from own or any other source to render it potable in
accordance with standard specified by BIS and water is stored
ensuring freedom from microbiological growth
Whether water tank are cleaned periodically and record
maintained there of
Disposal of waste: Whether the unit has obtained consent for air and water from
pollution control board
Whether pest control is done regularly
Whether personal handling Beta lactum antibiotics are tested
from penicillin sensitivity before employment
Whether personnels in handling of sex hormones cytotoxic and
other portent drugs are periodically examined for adverse
effect. They should be moved out by rotation
Whether all personnels have undergone medical examination
including eye examination and all free from Tuberculosis, Skin
and other communicable or contagious diseases and record
are maintained thereof
Whether all personnels are trained to ensure high level of
Personnel hygiene
Raw material
Whether the records of Raw materials are maintained as per
schedule U
Whether approved vendor list is provided
Documentation Record
Whether the records are made at the time of each operation in
such a way that all significant activities concerning to the
production are traceable. Records and SOPs to be retained
at least one year after the expiry of finish products during which
all relevant datas should be readily available.
Self Inspection and Quality Audit: Whether the firm has constituted a self inspection team
supplemented with a quality audit procedure to evaluate that
GMP is being followed
Quality Control System:Whether SOPs are available for sampling, inspecting, testing of
Raw Materials Finish products and Packing Materials and also
for monitoring environmental conditions.
Whether all instruments are calibrated and testing procedure
validated before they are deducted for routine testing
Whether Pharmacopoeias, reference standards, working
standards and technical books as required are available
Specifications:Whether specifications for Raw Materials, Packing Materials,
Product containers enclosures, Finish Products, In process and
Bulk products, for preparation of containers and closures are
Available and is complied with as per rules
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Master Formula Records:Whether the unit has maintained Master Formula Records
relating to all manufacturing procedures and batch sizes as per
rules
Packaging Records:Whether Authorised packaging instructions for each products,
pack size and type are maintained and complied with as per
rules.
Batch Processing Records:Whether the Batch Processing Records for each products on
the basis of currently approved master formula is being
maintained as per rules
Standard Operating Procedure and Records:Whether SOPs and records are being maintained and
complied with as per rules. Check whether following SOPs are
available
a) SOP for receipt of material
b) SOP for internal labeling, quarantine, storage, packaging
material and other materials
c) SOP for each instrument and equipment
d) SOP for sampling
e) SOP for batch numbering
f) SOP for testing
g) SOP for equipment assembly and validation
h) SOP for Analytical apparatus and calibration
i) SOP for maintenance, cleaning and sanitation
j) SOP for training and hygiene for the personal
k) SOP for retaining reference samples
l) SOP for handling, re-processing and recoveries
m) SOP for distribution of the product
Validation and Process Validation:Whether validation studies of processing, testing and cleaning
procedures are conducted as per rules
Product Recalls:Whether the prompt and effective recall system of defective
products is being maintained by the unit along with SOPs for
recall Operations
Complaints and Adverse Reactions:Whether the unit has maintained review system for complaints
concerning the quality of products along with SOPs
Site Master File:Whether Site Master File as per rules have been prepared &
maintained.
Sales Invoices (Domestic & Export) during last Licensing period.
Copies of New drugs, if any, permitted to manufacture during
last Licensing period
