Complaints: Complaints and evaluation of complaints, Handling of return
good, recalling and waste disposal.
Document maintenance in pharmaceutical industry: Batch Formula Record, Master Formula Record, SOP, Quality audit, Quality Review and Quality documentation, Reports and documents, distribution records
DOCUMENT MAINTENANCE IN PHARMACEUTICAL INDUSTRY
SYNOPSIS:
1. BATCH FORMULA RECORD/BATCH MANUFACTURING RECORD
2. MASTER FORMULA RECORD
3. STANDARD OPERATION PROCEDURES (SOP)
4. QUALITY AUDIT
5. QUALITY REVIEW AND QUALITY DOCUMENTATION
6. REPORT AND DOCUMENTS
7. DISTRIBUTION RECORDS
DOCUMENTATION:
BATCH FORMULA RECORD/BATCH MANUFACTURING RECORD
DEFINITION:
Batch Processing Record can also be said as Batch Manufacturing Record (BPCR)
“The Batch Manufacturing Record (BPCR) is the necessary quality and GMP documentation for tracing the complete cycle of manufacture of a batch or lot”
BATCH MANUFACTURING RECORD
1. Structure of BMR varies from company to company, it is possible to highlight their common element.
2. BMR may be prepared in local language
3. Content and layout of BMR should be
• Starting material
➢ It should be identified with their standard names and codes
• Issue formula
• Date and time (when appropriate)
• The quantity of the specific batch size with sufficient precision
• Title of materials
• All ingredients with complete description with procedure to be followed
➢ Calibration record
➢ Distribution records
➢ Quality control records
• Precaution to be followed
• Equipment to be used (e.g., Reactor, drier, mills, etc.)
• Any sampling performed
• Suitable quality control to be taken
• Appropriate label with container
• Manufacture worksheet bearing identification number. Material ticket for each raw material are written and issued by production department to department of material store, where orders are filled and verified
• After material sent to the production department and checked, addition of raw material to batch is verified and countersigned by qualified personal.
• Appropriate label is attached to each container or piece of equipment in use to identify its contents and to ensure that in process stage is properly designated.
• Any deviation from standard operation condition, should be reported to both
production and control personnel responsibility for product
• In process checking during manufacturing plays an important role in auditing of quality of product at various stage of production
• Duties of auditor/control inspector consist of checking, enforcing, reviewing
procedure and suggesting change for upgrading procedure when necessary
• Primary objective of IPQC system is to monitor all the feature of product that may affect its quality and to prevent error during processing
• At completion of manufacturing process as well as in process stage, actual yield are checked against theoretical value.
• Representative sample are withdrawn for lab testing by control inspector
SPECIFICATION:
• Bureau of Indian Standards (BIS) has prepared specifications for various packing materials.
• These specification are given prefix as “IS” means “Indian Standards”
• There are 18210 numbers of Indian Standards
• Certain specification amongst them are specifically prepared for pharmaceutical
industry, while the rest are general specifications.
SPECIFICATION FOR RAW MATERIALS:
I. Generic and chemical name of material
II. Trade name or product code established by manufacture
III. Description
IV. Name of pharmacopoeia or any other recognized book of standards in which
monograph appears or INN (International Non-proprietary Name)
V. Approved supplier
VI. Frequency of testing of stored material
VII. Special precautions to be taken during storage including safety aspects
VIII. Date of issue of specification
SPECIFICATION OF FINISHED PRODUCT:
I. Generic name of product
II. Trade name
III. Dosage form and strength
IV. Description (color, state, dimension, taste)
V. Physical properties (weight/volume (with limit), pH, Viscosity, Density, Hardness, Friability, Disintegration time, Dissolution time etc.,)
VI. Name of the Pharmacopoeia as a reference
VII. Date of Expiry
VIII. Precautions during storage including safety aspects
IX. Date of issue of specification
PREPATION OF MASTER FORMULAE:
Master formula prepared by compete technical staff It should be reviewed by heads of production, quality control department and research & development
DESCRIPTION
• Name and strength of the product along with dosage form’
• MFR No.
• A complete list of all ingredients with their quality
• Description of Containers, Closures and Packing materials to be used
• Description of all Vessels and Equipment used in the process
• Processing and Packing Instruments
• IPQCs to be taken during processing and packing
• Precautions to be taken during manufacture and storage of semi-finished product including any specific storage condition
➢ To facilitate consistent conformance to quality system requirements and to
support data quality
➢ To provide guidelines for accurate and timely data collection
➢ Uniformity of performance
BENEFITS:
• Provides information to perform job properly
• Serve as a training document for users
• Minimizes variation and promotes quality.
• Also provide, consistency (very important)
• SOP assist to ensure that GMP is followed and achieved at all time
• SOP’s help to assure the quality and consistency of the services, and thus
minimize harm to the patient
TYPES OF SOP:
✓ Analytical method
✓ Preparation of Reagent
✓ Quality Assurance
✓ For operating instruments, equipment and apparatus
✓ Safety & Precautions
✓ Methodic
✓ Receiving and registration of sample
✓ Fundamental SOP
✓ To deal with complaints
DO’s
i. Write in present tense
ii. Avoid ambiguity and be concise
iii. Reduce the word count where possible without changing the meaning of the text
iv. Keep the words short and get to point
v. Highlight exception. Use a symbol to flag that this is an exception and how to
handle it
vi. Highlight warning and use a larger or a warning icon.
DON’Ts
i. Don’t use past tense, condition of future tense unless you have good reason to do so
ii. Introduce acronyms without explaining what it means.
iii. Don’t use the word “may” “if possible” as it implies that the user can do something under conditions. Instead be positive and tell them what to do
CONTENT OF SOP:
• Company name and pagination
• Title
• Identification
• Review and approval
• Purpose
• Scope
• Responsibility
