SCHEDULE M – GMP – PART 1: GOOD MANUFACTURING PRACTICES FOR PREMISES AND MATERIALS

“Schedule M” outlines the guidelines set by the World Health Organization (WHO) for pharmaceutical product manufacturing, ensuring the quality and safety of both the products and their production processes.

GENERAL REQUIREMENTS: SCHEDULE M

• Location and Surroundings: The pharmaceutical manufacturing facility must be situated and equipped in a way that minimizes the risk of contamination from external sources such as open sewage, drains, public toilets, or other nearby factories emitting unpleasant odors, fumes, excessive soot, dust, smoke, or hazardous biological or chemical emissions.
• Building and Premises: The factory buildings must be appropriately designed, constructed, and maintained to accommodate pharmaceutical manufacturing activities under hygienic conditions. The premises should be compatible with different drug manufacturing operations carried out in the same or neighboring areas. They must provide adequate working space for the orderly arrangement of equipment and materials while ensuring proper movement of personnel to avoid cross-contamination, mix-ups, or product contamination.
  • The interior surfaces (walls, floors, ceilings) should be smooth, crack-free, and easily cleanable.
  • Areas where drug manufacturing occurs should be air-conditioned as necessary, well-lit, and adequately ventilated with air control systems to maintain required environmental conditions, including temperature and humidity, as defined for specific products.
  • Proper drainage systems, adequately sized and designed to prevent backflow and pest entry, must be in place.
  • The premises should be free from insects, pests, birds, and rodents, and regular cleaning and maintenance records should be kept.
• Water System: The facility must have a validated water treatment system to produce potable water meeting relevant standards. This purified water should only be used for processes that don’t involve direct product contact (except for cleaning operations, where potable water may be used). Water storage tanks should prevent contamination and microbiological growth, with regular cleaning and maintenance records maintained.
• Waste Disposal: Waste, including sewage, effluents (solid, liquid, and gas), must be disposed of in accordance with environmental regulations. Biomedical waste should be destroyed following the Bio-Medical Waste Management and Handling Rules. Special care should be taken for the safe disposal of rejected drugs, and records must be kept for all waste disposal activities.
• Warehousing: Warehousing areas must be designed to facilitate the safe and organized storage of various materials, including raw materials, packaging materials, bulk products, finished goods, and returned or recalled items. These areas should be kept clean, dry, and at suitable temperatures. Special storage conditions, like temperature and humidity control, should be monitored and recorded.
  • The storage areas should also have pest control measures in place, and materials should be stored in dedicated sections to avoid contamination and mix-ups.
  • Special areas should be designated for hazardous, poisonous, or explosive materials, with adequate fire protection measures in place.
  • Printed packaging materials should be stored separately and securely.
• Production Area: The production area should follow a logical sequence, preferably in a unidirectional flow, to avoid cross-contamination. Dedicated facilities should be provided for sensitive or potent products like penicillin, sex hormones, or cytotoxic drugs. Proper equipment positioning and adequate space should minimize the risk of contamination and operational errors.
• Ancillary Areas: Restrooms, locker rooms, and maintenance workshops should be separate from manufacturing areas. These areas should provide suitable facilities for workers’ hygiene and cleanliness, with proper sanitation procedures in place. Storage for tools and spare parts should be located away from production areas, and any equipment entering sterile areas must be disinfected.
• Quality Control Area: The Quality Control Laboratories should be isolated from production areas and designed for the specific testing operations (chemical, microbiological, etc.). These laboratories must have adequate space to avoid contamination and mix-ups and be equipped with the necessary resources for storing test samples, reagents, and records.
• Personnel: Manufacturing operations should be conducted under the supervision of qualified technical staff. Personnel handling sensitive or hazardous materials should undergo regular health checks and training to ensure safety and product quality. Workers should observe strict personal hygiene practices, and any personnel showing signs of illness or open lesions should be restricted from handling materials.
  • Specific personnel handling Beta-lactam antibiotics or other potent drugs should be periodically tested for sensitivity to prevent health risks.

Manufacturing Operations and Controls

• All manufacturing activities must be conducted under the supervision of qualified technical personnel authorized by the Licensing Authority. Every critical step, particularly the selection, weighing, and measuring of raw materials during various stages of production, should be carried out by trained individuals under the direct supervision of approved technical staff.
• Each vessel or container involved in manufacturing or storage throughout various stages should be prominently labeled with the product’s name, batch number, batch size, and stage of production. These labels should be signed and dated by the authorized technical staff to verify the information.
• For products not produced under aseptic conditions, it is crucial to ensure they are free from harmful pathogens such as Salmonella, Escherichia coli, and Pseudomonas aeruginosa, among others.

Precautions Against Mix-up and Cross-Contamination

• The licensee is responsible for preventing the mix-up and cross-contamination of drug materials and products (from environmental dust) through effective air-handling systems, pressure differentials, proper segregation, clear status labeling, and adequate cleaning. Detailed records and Standard Operating Procedures (SOPs) should be maintained for these processes.
• Sensitive drugs such as Beta-Lactam antibiotics, sex hormones, and cytotoxic substances should be processed in isolated areas or designated production zones with independent air-handling systems and proper pressure differentials. The segregation of these areas must be documented with adequate records of maintenance and services.
• To avoid mix-ups during production, materials being processed must be clearly labeled to indicate their status. All equipment used in production should also be labeled accordingly.
• Packaging lines should be independent and adequately segregated. At the end of each shift, any remnants from previous packaging, such as labels, cartons, and caps, must be cleared away to prevent contamination or mistakes.
• Before commencing packaging operations, it is essential to ensure that the work area, packaging lines, printing machines, and other relevant equipment are clean and free from leftover products, materials, or spills. A checklist should be used for line clearance, and this process should be documented.
• The details of any printed information (e.g., batch numbers, expiry dates) must be cross-checked regularly. Any printing and reprinting should be authorized in writing to ensure accuracy.
• The manufacturing environment must meet the necessary temperature, humidity, and cleanliness standards.
• Authorized personnel should change into designated uniforms before performing any manufacturing tasks, including packaging.
• Segregated, enclosed areas must be designated for recalled or rejected materials, as well as for materials that are to be reprocessed or recovered.

Sanitation in Manufacturing Premises

• Manufacturing premises should be regularly cleaned and kept organized to prevent the accumulation of waste, dust, or debris. A validated cleaning procedure must be in place and followed.
• Manufacturing areas should not be used for storing materials except for those being processed. These areas should not serve as general thoroughfares.
• A detailed sanitation program must be established, outlining specific areas to be cleaned, cleaning intervals, and the procedure to follow. The program should also designate the personnel responsible for cleaning.
• The manufacturing environment should be spacious enough to allow for the logical organization of equipment and materials, minimizing the risk of cross-contamination, errors, and improper application of manufacturing or control procedures.
• Production areas must be well-lit, especially where visual on-line controls are necessary.

Raw Materials

• The licensee must maintain an inventory of all raw materials used at any stage of production and keep records of these materials.
• Upon receipt, all raw materials should be quarantined immediately. These materials should be stored properly to facilitate batch segregation and stock rotation, adhering to a first-in, first-out (FIFO) principle.
• Materials should only be purchased from approved suppliers, and wherever possible, directly from the producers. All raw materials must be accompanied by a valid purchase order.
• Authorized personnel from the Quality Control Department (QC) should inspect each consignment upon receipt, ensuring that containers are intact, and any damaged materials should be identified and segregated.
• If materials from different batches are delivered in one consignment, each batch should be treated as a separate batch for testing and release.
• Raw materials must be clearly labeled, with information including the product’s name, internal code, batch number, manufacturing and expiry dates, re-test dates, and status (e.g., quarantine, under test, approved, or rejected).
• There should be designated storage areas for materials under testing, approved materials, and rejected materials. These areas should be equipped to maintain appropriate temperature and humidity conditions.
• Containers from which samples have been drawn should be properly identified, and only raw materials released by the QC Department and within their shelf life should be used. The shelf life of the finished product should not exceed that of the active raw materials used in its manufacture.
• Raw materials should be stored on raised platforms or racks and not placed directly on the floor.

Equipment

• Equipment should be designed, constructed, and maintained to support the operations to be performed, minimizing the risk of errors. The layout of the equipment should also facilitate easy cleaning and maintenance to avoid cross-contamination or buildup of dirt and dust.
• All measuring equipment, including balances, should be calibrated and checked on a scheduled basis. These checks should be documented according to established SOPs.
• The equipment parts that come into contact with products must not react or contribute to contamination. Non-toxic, edible-grade lubricants should be used wherever applicable to prevent accidental contamination.
• Any defective equipment must be removed from production or properly labeled to indicate its status.

Documentation and Records

• Documentation is critical to maintaining compliance with Good Manufacturing Practices (GMP). It should define specifications for materials, manufacturing methods, and quality control measures, ensuring traceability and providing an audit trail for investigating suspected defects in any batch.
• All documents must be reviewed and approved by authorized personnel. The documents should specify their purpose, be clear and legible, and be regularly updated. Any alterations should be signed and dated.
• Records should be maintained for at least one year after the expiry date of the finished product. These records can be generated through electronic systems, provided there is a hard copy backup available for validation.
• Batch records should be securely stored and protected by backup systems. Critical data should be accessed only by authorized personnel, and changes to records should be tracked.

Labels and Printed Materials

• Labels are crucial for identifying products and ensuring proper usage. Labels should be printed clearly and in bright colors for visibility.
• All containers and equipment should have appropriate labeling, with color-coded labels indicating the product’s status (e.g., under test, approved, rejected).
• To prevent mix-ups, printed packaging materials, including product leaflets, should be stored separately.
• Before release, labels for containers, cartons, and boxes, as well as inserts and leaflets, must be inspected by the QC Department to ensure they conform to the specifications.
• Before packaging and labeling any batch, the licensee must ensure that samples have been tested, approved, and released by QC personnel.
• Records should be maintained for the receipt of all labeling and packaging materials, including control reference numbers and acceptance or rejection statuses.

Quality Assurance

• Quality assurance encompasses all aspects that influence the product’s quality, ensuring that pharmaceutical products are designed and manufactured according to GMP guidelines.
• The quality assurance system must ensure that products are produced with the correct raw materials and packaging materials, that adequate controls are in place during manufacturing, and that finished products are tested according to established procedures.
• No product should be released for sale or distribution until it has been certified by authorized personnel, confirming that it has been produced and controlled according to the required standards.

Self-Inspection and Quality Audit

• Self-inspection procedures help manufacturers assess their adherence to GMP in all areas of production and quality control. An independent team of qualified individuals should regularly audit these processes.
• The self-inspection program should identify areas of non-compliance, recommend corrective actions, and track improvements. Inspections should be routine and occur when product recalls or repeated rejections happen or when an external audit is scheduled.
• Written procedures for self-inspection should cover various aspects, including personnel, premises, equipment, sanitation, production controls, quality control, and validation.

Quality Control System

• Quality control involves the systematic sampling, testing, and documentation necessary to ensure that products meet the required standards before release.
• A dedicated quality control laboratory, staffed by qualified professionals, should be in place to monitor raw materials, in-process products, and finished goods.
• No batch should be released for sale or supply until it has been tested and certified by QC personnel to meet all specifications.
• Reference samples should be retained for each batch, and stability studies should be conducted to determine the shelf life of products.
• Calibration of instruments and validation of testing procedures should be routinely performed, and specifications for raw materials and products should be regularly reviewed and updated by the QC department.

Specification

• For Raw and Packaging Materials:

The specifications for raw and packaging materials should include:

• • The designated name and internal reference code.
  • Any relevant pharmacopoeia monograph references.
  • Qualitative and quantitative criteria with defined acceptance limits.
  • Manufacturer’s or supplier’s name and address, along with the original manufacturer.
  • A sample of printed materials.
  • Instructions for sampling, testing, or references to testing procedures.
  • Storage conditions.
  • Maximum storage time before retesting is required.
• For Product Containers and Closures:

All containers and closures used must comply with pharmacopoeia standards. Appropriate validated test methods, sample sizes, specifications, cleaning, and sterilization procedures (when required) must be followed to ensure the materials do not adversely affect the quality or purity of the drug. Second-hand or reused containers and closures are prohibited.

• • When bottles are used, there should be a written cleaning schedule to follow. If bottles are not dried after cleaning, they must be rinsed with de-ionized or distilled water.
• For In-Process and Bulk Products:

Specifications for in-process materials, intermediates, and bulk products must be available and authenticated.

• For Finished Products:

Finished product specifications should include:

• • The product’s designated name and reference code.
  • The formula or reference to the formula and any pharmacopoeia references.
  • Sampling and testing instructions or a reference to procedures.
  • Description of the dosage form and packaging.
  • Qualitative and quantitative requirements with release limits.
  • Storage conditions and any special precautions.
  • Shelf-life details.
• For Container and Closure Preparation:

The specifications listed do not cover machinery, equipment, or premises required for preparing containers and closures for various dosage forms. The suitability of machinery, equipment, and premises should be assessed based on each licensee’s needs.

Master Formula Records

Master Formula records must be available for every manufacturing procedure corresponding to each product and batch size. These records must be created and approved by qualified technical staff, including the heads of production and quality control. The Master Formula should include:

• Product name and reference code.
• Patent or proprietary name, along with the generic name, dosage form, strength, composition, and batch size.
• Details of all starting materials, including quantities and references, with any substances that may be lost during processing.
• Expected final yield and acceptable yield limits, along with relevant intermediate yields (if applicable).
• The processing location and key equipment to be used.
• Methods or references for preparing critical equipment (including cleaning, assembling, calibrating, sterilizing).
• Step-by-step processing instructions, including timeframes for each step.
• In-process control instructions and limits.
• Storage conditions for products, including packaging, labeling, and any special requirements.
• Any special precautions.
• Packing instructions and sample labels.

Packaging Records

Each product, pack size, and type must have authorized packaging instructions that include:

• Product name.
• Description of dosage form, strength, and composition.
• Pack size, either in doses or the weight/volume in the final container.
• A complete list of packaging materials, including types, quantities, and specification reference numbers for each material.
• Reproduction of printed packaging materials with batch number and expiry date details.
• Any special precautions, including ensuring a clear work area before packaging begins.
• Description of the packaging operation and the equipment used.
• In-process control details with instructions for sampling and acceptance.
• After packaging and labeling, a reconciliation must be performed to compare the number of units labeled, packed, and returned or destroyed. Any discrepancies should be investigated before batch release.

Batch Packaging Records

A batch packaging record must be maintained for each batch or part batch processed, based on the packaging instructions. The preparation method should minimize transcription errors.

• Before packaging begins, ensure the equipment and workspace are free of any unrelated materials, and that equipment is clean and suitable for use.

Batch Processing Records

A batch processing record must be maintained for each product, based on the approved Master Formula. The record preparation method should minimize transcription errors.

• Before processing begins, confirm the equipment and workspace are clear of any unrelated materials, and that equipment is clean and suitable for use.
• During processing, the following information should be recorded:
  • Product name and batch number.
  • Dates and times for commencement, significant intermediate stages, and completion.
  • Initials of operators for significant steps, with verification from the person overseeing these operations.
  • Batch and/or analytical control numbers, including quantities of materials used.
  • Relevant processing details and major equipment used.
  • In-process control records, with initials of the responsible person and results.
  • Yield data at various critical stages.
  • Explanations for deviations from expected yield limits.
  • Documentation of any special problems or deviations from the Master Formula with signed authorization.
  • Details of any recovered or reprocessed materials, including recovery/reprocessing stages.

Standard Operating Procedures (SOPs) and Records

Receipt of Materials:

There must be written SOPs and records for receiving raw, primary, and printed packaging materials.

• The receipt records should include:
  • Material name, delivery note, and container quantity.
  • Date of receipt.
  • Manufacturer or supplier name and batch/reference number.
  • Total quantity and number of containers.
  • Control reference number assigned after receipt.
  • Any other relevant information.

There should also be SOPs for internal labeling, quarantine, and storage of materials, as well as for each instrument and equipment, placed close to the relevant device.

Sampling:
Written SOPs for sampling should specify authorized personnel and include:

• Sampling methods and plans.
• Equipment and precautions to prevent contamination or deterioration.
• Sample quantity, subdivision, or pooling instructions.
• Container types for samples.
• Special precautions, especially for sterile or hazardous materials.

Batch Numbering:

There must be SOPs detailing batch number allocation to ensure each batch is identified by a specific number. These procedures should ensure traceability to demonstrate that products in different processing or packaging stages come from the same homogeneous batch.

Testing:
Written procedures for testing materials and products at different stages must include test methods, equipment, and required records.

• The records should cover:
  • Material or product name, dosage form, batch number, and manufacturer.
  • Testing methods, results, observations, and calculations.
  • Dates of testing, personnel initials, and release or rejection statement.

Reference Samples:

Samples of active ingredients, in sufficient quantity to conduct all required tests (except for sterility and pyrogens testing), should be retained for 3 months after the expiry date of the last batch produced from that active ingredient.

Samples of finished products must be stored in the same or equivalent containers in which the drug will be marketed.

Reprocessing and Recoveries:

If reprocessing is necessary, written procedures should be established and approved by the Quality Assurance Department. These procedures must specify the conditions and limits for repeating chemical reactions.

• Re-processed batches must be validated, and the causes for reprocessing must be investigated and corrective actions taken. A stability evaluation should be performed on re-processed batches.
• Recovered product residues may be reused if permitted, with specific documentation in the master production and control records.

Distribution Records:

Before distribution, a batch must be tested, approved, and released by quality control personnel. Pre-dispatch inspections should ensure only correct goods are sent. Distribution centers should follow standard operating procedures for warehousing, and periodic audits should be performed.

• Distribution records should enable traceability to facilitate quick and complete batch recalls if necessary.

Validation and Process Validation in Pharmaceutical Manufacturing

Validation is a cornerstone of Good Manufacturing Practices (GMP), ensuring that pharmaceutical products meet their required quality standards consistently. In pharmaceutical manufacturing, it is crucial to perform validation studies in accordance with predefined protocols to guarantee that processes, testing, and cleaning procedures are reliable. This detailed process helps to verify that every stage in production is capable of consistently delivering the intended product quality.

Importance of Validation

Validation studies are essential components of GMP as they provide evidence that manufacturing processes consistently produce quality products. These studies cover a wide range of activities, including validation of manufacturing processes, testing procedures, and cleaning procedures. Each of these processes requires systematic assessment and documentation to ensure that they function as expected under various conditions.

A report summarizing the recorded results and the conclusions drawn from these validation studies must be prepared. This report is maintained as part of the company’s documentation to ensure traceability and accountability. The validated processes, established based on these studies, must undergo periodic revalidation to ensure their ongoing effectiveness.

Continuous Revalidation

As processes and procedures evolve, periodic revalidation is essential to maintain their ability to meet intended results. This helps companies identify potential issues before they compromise product quality. Critical processes, particularly those that involve high-risk activities, must be validated prospectively (before the process begins) or retrospectively (after the process has been in place for a while) to ensure consistency and reliability.

New Formulations and Methods

When new formulations or methods are introduced, steps must be taken to demonstrate their suitability for regular processing. This may involve validating new methods, materials, or equipment to ensure they consistently yield a product of the desired quality. New methods should be proven reliable before they become part of routine production.

Changes in Manufacturing

Any significant modifications in manufacturing, such as changes to equipment, materials, or methods, must also undergo validation. Even minor adjustments can affect product quality and process reproducibility. Therefore, validating these changes ensures that the process remains capable of producing consistent and high-quality products.

Product Recalls: Essential Procedures for Effectiveness

In any manufacturing process, there is always the potential for defective products to reach consumers. In such cases, it is essential to have a product recall system in place that can swiftly and effectively retrieve the defective products. This system should be capable of providing timely information to all stakeholders, including stockists, wholesalers, and suppliers, all the way down to the retail level.

Effective Recall System

A reliable recall system includes a clear, written procedure (such as a Standard Operating Procedure or SOP) that allows for the rapid initiation of recall activities. This ensures that all defective products are swiftly identified and removed from the distribution channels. Whether through print or electronic media, the recall system should allow for immediate communication with all parties involved.

Record Keeping and Reconciliation

A key element of the recall process is maintaining accurate distribution records. These records must be readily available to those tasked with conducting the recall. After the recall is complete, a final report should be created, including a reconciliation of the delivered and recovered quantities. This step ensures that all affected products are accounted for, preventing any defective products from remaining in circulation.

Recalled Products and Secure Storage

Once recalled products are retrieved, they must be stored in a secure, segregated area. This ensures that they are isolated from other products and can be handled appropriately as decisions regarding their disposition are made.

Evaluation of Recall Effectiveness

The effectiveness of the recall system should be periodically evaluated. Regular assessments help to identify any shortcomings in the process and facilitate improvements to ensure that future recalls are more efficient.

Managing Complaints and Adverse Reactions in Pharmaceuticals

Product quality is paramount in the pharmaceutical industry, and any complaints or adverse reactions must be handled carefully. Complaints regarding product quality should be thoroughly investigated by the designated personnel to ensure that any issues are identified and addressed.

Systematic Review of Complaints

A robust system for handling complaints involves recording each complaint and following a detailed investigation protocol. The results of this investigation should be documented, along with any corrective actions taken to resolve the issue. In cases where serious adverse reactions occur, these must be reported immediately to the appropriate licensing authority.

Reporting Adverse Drug Reactions

Adverse reactions resulting from drug use should be reported promptly to regulatory authorities. A comprehensive report that includes all relevant documentation and comments should be prepared to ensure compliance with regulations and the safety of patients.

Product Recalls Due to Complaints

When a complaint involves a defect or adverse reaction that may require a product recall, there must be a clear procedure outlining how to initiate the recall and handle the defective product.

Site Master File: Comprehensive Documentation of Manufacturing Facilities

A Site Master File (SMF) is a vital document that provides detailed information about the manufacturing site, its operations, and its compliance with GMP. The SMF serves as a comprehensive reference document for regulatory authorities and internal stakeholders, offering insights into the structure and activities of the manufacturing facility.

General Information

The SMF includes a brief overview of the company, detailing its manufacturing activities and the types of products licensed for production. It also outlines any other manufacturing operations carried out on the premises and includes flow charts that demonstrate procedures and process flows for better clarity. The number of employees working in production, quality control, storage, and distribution is also documented. Additionally, the use of external scientific, analytical, or technical assistance in relation to manufacturing is noted, highlighting any third-party contributions.

The quality management system of the firm is briefly described, along with information about products registered for export to foreign countries. This comprehensive documentation helps ensure transparency and accountability in the operations of the manufacturing site.

Personnel

The SMF must include an organizational chart that shows the arrangements for quality assurance, including the roles of personnel in production and quality control. Key personnel qualifications, experience, and responsibilities should be clearly outlined. Training programs and the records of personnel training should also be documented, ensuring that employees are well-equipped for their roles. Health and personal hygiene requirements, including clothing standards, should be specified to maintain a clean and safe working environment.

Premises

A detailed description of the manufacturing premises is necessary, including a floor plan of the manufacturing areas and the nature of construction and fixtures. Information on ventilation systems should also be provided, particularly for critical areas that pose a risk of airborne contamination. Special areas for handling hazardous or sensitizing materials must be designated, along with a description of water systems, sanitation procedures, and preventive maintenance programs.

Equipment

The SMF should also contain a description of the major equipment used in production and quality control. The planned preventive maintenance programs for equipment must be documented, including the recording system used for tracking maintenance activities. Furthermore, systems for equipment qualification and calibration should be detailed, along with arrangements for the validation of computerized systems.

Sanitation and Documentation

The SMF must ensure that there are written specifications and procedures for cleaning manufacturing areas and equipment. Proper documentation systems must be in place for the preparation, revision, and distribution of necessary documents related to the manufacture of products, including microbiological control documentation for air and water systems.

Production and Quality Control

Details about the production process should be outlined, including flow charts that specify important parameters for each stage. Information on the handling of starting materials, packaging materials, and finished products should be included, with particular attention paid to quarantine, release, and storage procedures. Additionally, a brief description of the company’s policy on process validation should be provided to ensure product consistency.

The quality control system and the activities of the quality control department must also be described. This includes the procedures for releasing finished products and handling any variations or defects during production.

Compliance and Export Considerations

In the context of loan manufacturing and licensing agreements, it is essential to assess the compliance of the loan licensee with GMP regulations. This includes monitoring their adherence to manufacturing protocols and ensuring that quality control measures are followed.

Additionally, for products intended for export, the SMF should outline the exportation process, including the handling of any complaints or product recalls specific to international markets. This ensures that export products meet the same rigorous standards expected within domestic markets.

In summary, robust validation processes, effective product recall systems, careful management of complaints and adverse reactions, and comprehensive documentation through the Site Master File are essential components of GMP. These elements work together to ensure that pharmaceutical products are manufactured consistently and safely, meeting the highest standards of quality and regulatory compliance.

For Specific Requirements For Manufacture Of Oral Solid Dosage Forms (Tablets And Capsules) Click Link: Schedule M – Gmp – Part 2 (Osd)