PRESENTED BY: GUIDED BY:

SWATHI M NAMBIAR PROFESSOR KRUPA THULA

M.PHARM SEM-1 ASSISTANT PROFESSOR

ROLL NO:1 M PHARM

PMRA

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L.J INSTITUTE OF PHARMACY

INTRODUCTION

MANUFACTURING DOCUMENTS

DOCUMENT CONTROL

MASTER FORMULA RECORDS

BATCH FORMULA RECORDS

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• Drugs are usually administered into different dosage

forms by converting them into suitable formulations.

• Dosage forms are carriers through which drug molecules

are delivered to the site of action within the body.

• Dosage form=DRUG + EXCIPIENTS

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DOSAGE

FORMS

VARIOUS

AVAILABLE

DOSAGE FORMS

INTO WHICH A

DRUG CAN BE

CONVERTED IS AS

DISPLAYED IN THE

IMAGE.

5FIGURE 1.1

To protect the drug from oxidation (e.g. Vitamin C, Ferroussulfate), hydrolysis (aspirin) and reduction e.g. coatedtablets, sealed ampoules.

Protection from gastric juice, e.g. enteric coated tablets.

Masking unpleasant taste and odor.

Provide drugs within body tissues, e.g. injection Sustainedrelease medication.

Facilitation of Insertion of drugs into body cavities (rectal,vaginal).

To provide a safe and convenient delivery of accuratedosage.

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DEFINITION:

As per ISO, documentation can be defined as:

“Information created, received and maintained as

evidence and information by an organization or

person, in pursuance of legal obligation or

transaction of business.”

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D- Design, development, deviations, dossiers, drug

master files for regulation purposes

O- Operational procedures/methods/techniques, out of

specifications(OOS), out of trends(OOS)

C- Cleaning, calibration, control, complaints, closures,

containers and contamination

U- User requirement specifications, utilities like water

systems, HVAC, AHU, etc.

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M- Man, materials, methods, maintenance,

manufacturing operations and control, monitoring,

master formula, manuals

E- Engineering control and practices, environmental

control, equipment qualification documents

N- Non-routine activities, new products and

substances

T- Technology, transfer, training, testing, trend

analysis, technical dossiers

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S- SOP’s, safety practices, sanitation, self inspection,

storage, standardization, standard test procedures, site

master file

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1) REDUCE COSTS

• Labour expense

• Improve productivity

• Decrease storage costs

• Decrease time and cost with managing compliance

program

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2) REDUCE CYCLE TIME

Shorten time to market

Improve order fulfilment

Supply chain collaboration

Support manufacturing

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3) INCREASE SERVICE LEVELS

Improve issue resolution methods

Share knowledge assets

Strengthen customer relations

Increases sales proficiency

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4) Compliance-Regulatory, Corporate Policies, AndCertification Assistance

ISO Compliance

FDA Compliance

OSHA Compliance

Corrective and Preventive Action (CAPA)Compliance

Sarbanes-Oxley (SOX) Compliance

Disaster Recovery practices

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5) Mainatainence of management

6) Information about equipment

7) Gives information about product, premises,

personnel,etc

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ACCOUNTING- Account receivables/payables

processing

CUSTOMER SERVICE- Order processing, complete

customer profiling, resolution handling

ENGINEERING- Change process management

HUMAN RESOURCES-Sensitive employee

management, hiring processing

OPERATIONS- Continuous improvement planning

initiatives, project management

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QUALITY ASSURANCE- Issue resolution,

documented standard processes, safety compliances

REGULATORY COMPLIANCE- Complete

document security and audit trial capabilities

RISK AVERSION-Complete disaster recovery, design

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Specification and standards

Raw Material Records

Labels and printed packaging material records

Master Formula Records

Batch Production Records

Quality Control Records

Calibration & Validation Records

Distribution Records

Batch Packaging Records

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Controlled documents are legible, dated, readily identifiable,

maintained in an orderly manner and retained for a specified

period.

Document control ensures that the documents are able to be

located, reviewed periodically and revised and approved.

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The main purpose is to introduce and establish a unified

system of document control.

It describes the procedures and responsibilities for

creation and modifications of controlled documents.

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The major responsibility rests on the QA personnel for

control of the documents.

Without the approval of the QA personnel no

manufacturing documents can be made legal or controlled.

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The procedure for control of the documents can be briefed asfollows:

All documents should be identified by a unique title anddocument number.

Document should be designed, prepared, received, approved,signed and dated by authorized persons and distributed toconcerned departments.

Approved documents should not be corrected manually with apen / pencil for any reason.

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The Master Formula can be prepared as a set of documents:one for each segment of the full production process (e.g.for the production of an intermediate such as a batch ofharvest or for the formulation/filling process from finalbulk), or a single overall document that contains partswhich describe the separate batch products that make upthe full process from the starting materials to the final validproduct.

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A document or set of documents specifying the starting

materials with their quantities and the packaging

materials, together with a description of the procedures

and precautions required to produce a specified quantity of

a finished product as well as the processing instructions,

including the in-process controls.

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Batch Manufacturing record (BMR).

Batch Packing record (BPR).

Intermediate/ Packing Material / Finished product

specification.

Specimen of Printed packaging material.

All documents of “ Master Formula Record” should be

stamped as “Master Copy” in Green at the non- text side

(back side).

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(a) the name of the product together with product reference coderelating to its specifications;

(b) the patent or proprietary name of the product along with thegeneric name, a description of the dosage form, strength,composition of the product and batch size;

(c) a statement of the processing location and the principalequipment to be used.

(d) name, quantity, and reference number of all the startingmaterials to be used. Mention shall be made of any substance thatmay .disappear. in the courts of processing.

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(e) a statement of the expected final yield with the acceptablelimits, and of relevant intermediate yields, where applicable.

(f) The methods, or reference to the methods, to be used forpreparing the critical equipment including cleaning, assembling,calibrating, sterilizing.

(g) detailed stepwise processing instructions and the time takenfor each step;

(h) the instructions for in-process control with their limits;

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(i)the requirements for storage conditions of the products,

including the container, labelling and special storage

conditions where applicable;

(j) any special precautions to be observed;

(k) packing details and specimen labels.

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The generally recommended MF format is to prepare a

single continuous document that provides step-by-step

production instructions, raw materials, equipment used,

locations of production, dates, operators, etc. for the

product, with blank spaces to record the data and

sign and date all entries, and at least cross-references to all

supporting SOPs and operations.

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34Figure 1.2 SPECIMEN OF MF

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A batch processing record is built up by filling in all theblanks on an approved Master Formulae sheets.

An approved copy of the MF is requested by theproduction department for each production run of a batch.

The Batch Processing Record Document must be verifiedby QA or QC as an exact replica of the current MF beforebeing Released for a batch production run.

It is ideal to have the batch processing record divided byday (see format in later section of this guide) so that onlythe required blank pages of the batch processing recordare taken into the production area for each day of aproduction run.

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All documents associated with the manufacture of a batch

of bulk product or finished product. They provide a

history of each batch of product and of all circumstances

pertinent to the quality of the final product.

Batch formula record should be prepared for each batch of

the product.

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Batch formula record shall be essentially based on the

master formula record and shall be compiled, checked,

approved and authorized by competent technical person

responsible for production and quality control. Photo

reproduction, or such other system (e.g. computer

printouts) shall be preferred to avoid transcription errors

provided, however, there are adequate safeguards to

prevent unauthorized re-production.

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Name of product

Batch formula

Brief manufacturing process

Batch or code number

Date of the start and finish of processing andpackaging

Identity of individual major equipment and lines orlocation used

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Records of cleaning and sanitation of equipment used for

processing as appropriate

In-process control and laboratory results, such as pH andtemperature test records

Packaging line clearance inspection records

Any sampling performed during various steps of processing

Any investigation of specific failure or discrepancies

Results of examinations on packed and labelled products

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41Figure 1.3 Specimen of BFR

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