Mfr
-
Upload
praveen-praveen -
Category
Business
-
view
1.753 -
download
1
description
Transcript of Mfr
DOCUMENTATION DOCUMENTATION PRACTICEPRACTICE
PRESENTED BY PRESENTED BY HARISH DHANASHREEHARISH DHANASHREE
I.M.PHARMA I.M.PHARMA DEPT OF PHARMACEUTICSDEPT OF PHARMACEUTICS
1
INTRODUCTIONDocument is a written report or record
that provides information especially of an official or legal nature.
Documentation is a method of preparing a written material, which describe the process in terms of specification, instructions etc.
2
Drug and cosmetic rules… The drugs and cosmetic rules under
the “conditions of licenses” and under schedule M require a manufacturer of drugs to maintain various records.
3
What documentation system consists…? Written specification Descriptions Procedures Instructions Observation/execution data.
4
Importance of Documentation It provides necessary working details. Reduces the risk of mistake. Help in tracing the deviation from the
expected yield. They help in decreasing the batch to batch
variation so that quality of product is kept within the limits of acceptability.
Considered as the history of batch operations.
Self-inspection of procedure.***Documentation and records are essential for obtaining accreditation,
certification of ISOs and approvals by Federal Bodies.
5
Documentation-Important Areas Particulars with respect to their storage,
stability and handling. Instruction for all manufacturing and
packaging procedure. Instruction for non-product related
operations. Procedure for testing. Specification of starting materials, packing
materials and products for the compliance by the quality control department.
6
MASTER FORMULA RECORDS
Master formula records are defined as written procedure that give the complete description of all aspects of its manufacture, packing and control with an infection to ensure the purity, identify, quality and strength of each dosage unit through its shelf life.It includes the following information,Specifying a fixed formulationIdentifying quality criteria for componentsProviding a set of manufacturing instruction in clear termsDescribing systematic sampling proceduresListing precise assays, tests etc.Establishing methods for ensuring complete accountability for all materials Including packing and labelling.
7
Types of Master Formula Records
The master formula records give proportion of ingredients in the formulation.
Master batch formula records, which specify absolute amounts of specific potent ingredients and excipients.
8
MASTER PRODUCTION AND CONTROL RECORDS
Master production and control records are defined as detailed written instructions including all operations starting from dispensing of raw materials till finishing of bulk products and packaging operation of a particular product.
Master production and control record includes batch size, date of manufacture and full signature (hand written) by one person and further independently checked, dated and signed by second person.
9
SEQUENCE OF 9 SUBSECTION10
11
BATCH PRODUCTION AND CONTROL RECORDS
12
Batch production and control records shall be prepared for each batch of drug product produced and shall include complete information relating to the production and control of each batch.
These records shall include: (a) An accurate reproduction of the appropriate
master production or control record, checked for accuracy, dated, and signed;
(b) Documentation that each significant step in the manufacture, processing, packing, or holding of the batch was accomplished.
BATCH PRODUCTION AND CONTROL RECORDS
13
Dates; Identity of individual major equipment and lines used; Specific identification of each batch of component or in-process
material used; Weights and measures of components used in the course of processing; In-process and laboratory control results; Inspection of the packaging and labeling area before and after use; A statement of the actual yield and a statement of the percentage of
theoretical yield at appropriate phases of processing; Complete labeling control records, including specimens or copies of all
labeling used; Description of drug product containers and closures; Any sampling performed; Identification of the persons performing and directly supervising or
checking each significant step in the operation; Any investigation made according to. Results of examinations made in accordance with.
RAW MATERIALS14
The schedule U to the drugs and cosmetic rules require following particulars to be shown in the raw material records:-
Date of receipt, Invoice number, Name and address of manufacturer/supplier, Batch number, Quantity received Pack size, Date of manufacture, Date of expiry Date of analysis and release/rejection by quality control, Analytical report number, Quantity issued, Date of issue, Name and batch number of the product for manufacture of which
issued, Proper disposal of stocks
FORMAT15
Date of receipt
Invoice number & date
Name &Address
of supplier
QtyRecd(pack size)
B. No.
Mfgdate
Expdate
Name &Address of manufactur
er
OpinionOf Q.C.Dept
QCReportNo.& Date
Name of the material:
RECEIPT
DateOf
IssueQty
issuedName & B. No.of product forwhich issued
BalanceParticulars of disposal if not
usedSign of issuing
person
ISSUE/DISPOSAL
Labels and printed packaging material records
16
The Indian GMPs require the records of labels and printed packaging materials indicating receipt, examination relating to testing and whether accepted or rejected to be maintained.
Labels What must be labelled?
-Containers, equipment, premises, products, intermediates, samples, standards etc.-Status (quarantined, accepted, rejected, clean)
Who has responsibility for labelling?-QC and production for status labels-Final product, intermediates, reagents etc.
Drug product container, closure, and labelling records.
17
These records shall include the following: The identity and quantity of each shipment of each lot
of components, drug product containers, closures, and labelling.
The results of any test or examination performed. An individual inventory record of each component,
drug product container, and closure and, for each component, a reconciliation of the use of each lot of such component.
Documentation of the examination and review of labels The disposition of rejected components, drug product
containers, closure, and labelling.
Drug product container, closure, and labelling records.
18
Date of receipt
Qty received
Invoice No Date, name &address
Consignmentnumber
Opinion of Q.C
Q.C. report No & date
Date Of issue
Qty issued
Batch .No for which issued
balance Particulars of disposal if not used
Sign of issuing person
Name of the material:
RECEIPT
ISSUE /DISPOSAL
QUALITY CONTROL RECORDS:
19
The quality control records must show:
The date of performance of test; Identification of material; Name of supplier(in case of raw materials) Date of receipt Batch number Quantity received (in case of raw materials)
(batch size in case of finished product) Date and quantity of sample taken Specifications employed for testing
20
All data secured in the course of each test including all graphs, charts, printouts etc
Calculations performed in connection with including units of measures, conversion factors and equivalence factor
A statement of the result of tests and how the results compare with established standards of identity, purity and strength
The initials or signature of person who performs the tests Certificate number issued Disposition of the quality control unit accepting or
rejecting the material.
REFERENCE21
Good Manufacturing Practice, Quality Control Guidelines, Basic Standard In the Manufacture Of Drugs Pharmaceuticals Companion Volume to Handbooks Of Drug Laws - By M.L. Mehra.
How to practice GMPs P.P.Sharma. Pharmaceutical Production And
Management, CVS subrahmanyam.
22
THANK THANK YOUYOU