MANUFACTURING DOCUMENTATION IN PHARMACEUTICAL INDUSTRY- DEVELOPMENT AND IMPLEMENTATION
Krunal Parikh1*, Mr. Maheshkumar Kataria2, Jatin Patel1
2Assistant professor, Department of pharmaceutics,
1Seth G.L. Bihani S.D. College of Technical Education,
Institute of Pharmaceutical Sciences and Drug Research,
Sri Ganganagar, Rajasthan, INDIA
Documentation is an integral part of good manufacturing practices. It defines a system of information and control so that risks so inherent in misinterpretation and/or error in oral communication are minimized. It consequently strengthens the quality, and its consistency, of all goods and services, as those responsible for the specific operations have clear, unambiguous instructions to follow including active drug substances, is legally mandatory.
Reference Id: PHARMATUTOR-ART-1525
Documentation is an integral part of good manufacturing practices. It defines a system of information and control so that risks so inherent in misinterpretation and/or error in oral communication are minimized.
It consequently strengthens the quality, and its consistency, of all goods and services, as those responsible for the specific operations have clear, unambiguous instructions to follow including active drug substances, is legally mandatory. (OPPI Guideline)
OBJECTIVES OF DOCUMENTS
1. To define the specifications and procedures for all materials and method of manufactured and control.
2. To ensure that all personal concern with manufacture know what to do and when to do it.
3. To ensure that authorized persons have all the information necessary to decide whether or not to realize a batch of a drug for sale.
4. To ensure the existence of documented evidence, trace ability, and to provide records and an audit trail that will permit investigation.
5. It ensures the availability of the data needed for validation, review and statistical analysis.
The design and use of document depend upon the manufacturer. (WHO, Vol.2)
Good documentation encompasses practically all the aspect of pharmaceutical production :
1. Building and premises: installation , validation , cleaning and maintenance
2. Personnel : Training, hygiene etc
3. Equipment : installation , calibration , validation , maintenance , cleaning
4. Materials: specification, testing, ware-housing, use, rejection/disposal.
5. Processing: individual steps in the process of manufacturing including controls thereof.
6. Finished goods: specifications, testing, storage, distribution, and rejection/disposal.
Complaints: investigation, actions (including recall, if necessary). (OPPI Guideline)
CHARACTERISTIC OF DOCUMENT
For effective use of documents, they should be designed and prepared with utmost care
Each document shall:
(i) Have a clear title.
(ii) Have an identification number.
(iii) Be approved by authorized person.
(iv) Have the date of issue
(v) Have a due date of revision.
(vi) List to whom it has been issued.
Where the documents carry instructions (e.g. batch processing)
i. The instructions shall be precise and not ambiguous.
ii. They shall be for each individual step and not combined.
E.g. Weigh the materials; charge the weighed materials into the blend
iii. Instructions shall be in imperative mood.
Where entry of any data (e.g. temperature, weight) is expected to be made by the person using the document:
i. Sufficient space shall be provided for making the entry.
ii. Heading shall clearly indicate what is to be entered, and who is responsible.
iii. All entries shall be in ink.
iv. All entries shall be clear and legible.
v. Person making the entries shall confirm the entry by initialing/signing the same.
vi. An error in entry shall be so corrected that the original (wrong) entry is not lost. such correction shall also be initialed and dated. Where necessary, reason for correction shall also be recorded, initialed and dated.
Documentation system should provide for a periodic review, and revision, if necessary, of any document, or part thereof.
Such revised versions shall also be approved by the authorized persons.
Updated/revised versions shall also be superseding the previous edition, and the document shall clearly indicate this.
Outdate/superseded document shall be immediately removed from active use, and copy retained only for reference. If documentation is through electronic data processing system (computerized system) there shall be adequate, reliable systems in place:
1. To check and ensure correctness of data.
2. To record changes (addition/deletion)
3. That meets other regulation requirement, if any. (Kate McCornick)
For implementing efficient documentation practices, which meet, full GLP/GMP/ISO and FDA requirements. Here is a hint from the “documents” model, which lists out the areas required for GMP document implementation:
D= Design, development, deviations, dossiers and Drug Master Files for regulated markets, distribution records
O= Operational procedures/techniques/methods, Out of specifications (OOS), Out of trend (OOT)
C= Cleaning, calibration, controls, complaints, containers and closures, contamination and change control
U= User requirement specifications, utilities like water systems, HVAC, AHU etc.
M= Man, materials, machines, methods, maintenance, manufacturing operations and controls, monitoring, master formula, manuals (quality, safety and environment), medical records
E= Engineering control and practices, Environment control, Equipment qualification documents
N= Non-routine activities, New products and substances
T = Technology transfer, training, testing, Trend analysis, Technical dossiers
S= SOPs, safety practices, sanitation, storage, self-inspection, standardization, supplier qualification, specifications and standard test procedures and site master file. (Quality Assurance)
MASTER FORMULA RECORD
Master formula record is a product specific document compiled, checked, authorized and approved by competent technical personnel from different. But interlinked, functions such as development, production, packaging and quality control as necessary and appropriate.
As with any other documentation master formula record shall also be open for review. Changes, if any shall also be approved by designated persons responsible for production and quality control.
Master formula record shall;
a. Give patent/proprietary name of the product, and its strength.
b. Give pharmacopoeial/generic name of the product, and its strength.
c. Give dosage form (e.g. tablet, ampoule) and physical characteristics of the product.
d. Give sufficient, detailed information of product pack and primary packaging materials.
e. Give identity, quality and quantity of every ingredient, including overages/assay value based quantities, if any, irrespective of whether, or not, the material.
1) Is an active drug substance in the formulation/product,
2) Is used as a pharmaceutical aid (excipient).
3) Appears, or is detected/tested in the final product.
f. Briefly describe all the raw materials
g. Give broad outlines of the process of manufacture (as a flow-chart, for example).
h. Give brief description of equipment/ machinery used for manufacturing the product.
i. Give step-wise manufacturing process.
j. Give theoretical and practical (expected) yields at different stages of manufacture.
k. Bring out in sufficient details precautions to be taken during manufacturing to ensure birth product quality and personnel safety.
l. Give all analytical controls, including limits thereof, applicable to the finished product.
m. Give stability test results covering the assigned shelf life..
n. Have a ‘product history’ data giving references in manufacturing/packaging introduced over the year.
o. (Preferably) contain samples of printed packaging components.
A format, which may be used as guideline for preparing master formula record , is as below
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